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The development of medical device starts with the need realized by a physician or surgeon. The device development is usually the result of this need and communication between him and engineer from a medical device supplying company. Although large medical device companies typically develop successive iterations of existing devices, most new device categories are typically developed by venture-backed start-up companies. Typically, a physician and/or engineer inventor conceives of a device solution to an unmet clinical challenge, initiates the patent process, and builds preliminary device prototypes. Preliminary bench and animal testing may be performed using the inventor’s or an acquaintance’s personal funding (angel investors). Further development typically requires engaging a team of engineers who work closely with physician advisors to bring the concept through the “design-build-test-redesign” cycle of bench and animal testing. This preclinical stage typically takes 2 to 3 years and depending on the nature of the device may consume US$10 to $20 million before the device is ready for clinical testing. These capital requirements exceed the means of most angel syndicates and are typically obtained from venture capital firms in the form of equity financing.A small percentage of device ideas are conceived in academic medical centers using federal or other grant funding. Few academic centers have the intrinsic capabilities to develop the device beyond the early prototype stage. Intellectual property is typically out-licensed to an existing company or start-up for further development. To facilitate the development of ideas that emerge out of federally funded programs, Congress passed the Bayh-Dole Act that assigns all intellectual property rights to the academic medical center.Initial Clinical TestingA start-up company’s survival is dependent on reaching milestones efficiently (in terms of time and money) to successfully raise additional funding. First clinical use is perceived by many as a key milestone, so that delays in the initiation of clinical testing programs can threaten a company’s viability. Companies will therefore seek the quickest path to first clinical use. US regulatory requirements are more extensive and require additional time and resources compared with those of other countries. It is estimated that obtaining Food and Drug Administration (FDA) approval to initiate clinical studies in the United States adds 3 to 6 months to the process of device development. In addition, subsequent review by the institutional review board (IRB) at the clinical site can add an additional 3 to 6 months to this timeline. Because of these factors, initial clinical device testing has shifted largely to outside of the United States. It is thus estimated that more than 75% of first clinical use cardiovascular device testing is now outside the United States, saving what may be 6 to 12 months when compared with US clinical initiation. When initial clinical testing is performed within the United States, it is estimated that only 25% of the work occurs at academic institutions. This is due in part to the bureaucracy associated with large academic institutions for both IRB approval and contract negotiations .Clinical testing of an unapproved significant-risk medical device requires FDA approval in the form of an Investigational Device Exemption (IDE). The IDE application provides information to the FDA on device design and qualification, as well as on the study protocol. The FDA is mandated to respond to the IDE application within 30 days.1 An IDE may also be required for studies in which an approved device is used for a purpose distinct from its approved indication.2 This is typically the case when a trial is sponsored by a company for the purpose of expanding the indication of a device or making significant changes in the instructions for use.Regulatory Approval Process (United States)Medical devices are regulated in the United States by the Center for Devices and Radiological Health (CDRH) of the FDA. The FDA/CDRH mandate is to promote and protect the public health by making safe and effective medical devices available in a timely manner. The standard for demonstrating safety and effectiveness is determined in part by the risk associated with the device in question. Devices are classified according to their perceived risk using a 3-tiered system (class I, II, or III).Class I devices (lowest risk) are subject to general controls, which are published standards pertaining to labeling, manufacturing, post-market surveillance, and reporting. Devices are placed into class I when there is reasonable assurance that general controls alone are adequate to assure safety and effectiveness. The general controls that typically apply to class I devices include prohibitions against adulteration and misbranding, requirements for establishing registration and device listing, adverse event reporting, and good manufacturing practices. Furthermore, remedies including seizure, injunction, criminal prosecution, civil penalties, and recall authority are provided to FDA. Formal FDA review is not required for most class I devices before their market introduction.Class II devices are those higher-risk devices for which general controls alone have been found to be insufficient to provide reasonable assurance of safety and effectiveness, but for which there is adequate information available to establish special controls. Special controls may include performance standards, design controls, and post-market surveillance programs. In addition, most class II devices require FDA clearance of a premarket notification application (PMA or 510[k]) before the device may be marketed. In the 510(k) application, the medical device manufacturer must provide data to demonstrate that the new device is “substantially equivalent” to a legally marketed device. Although substantial equivalence can usually be demonstrated on the basis of bench and animal testing alone, approximately 10% of 510(k) applications include clinical data.Class III devices, such as heart valves, pacemakers/implantable cardioverter-defibrillators, and coronary stents, are judged to pose the highest potential risk. These devices are either life-sustaining/supporting, of substantial importance in preventing impairment of human health, or present a high risk of illness or injury. Consequently, general and special controls alone are inadequate to provide reasonable assurance of safety and effectiveness. Most class III devices require FDA approval of a PMA before they can be legally marketed. Approval of the PMA generally requires clinical data demonstrating reasonable assurance that the device is safe and effective in the target population.The Human Device Exemption (HDE) is a new pathway to allow for commercialization of class III devices designed to address small markets, ie, diseases or conditions that affect fewer than 4000 patients in the United States each year. Approval of an HDE requires demonstration that the device is safe and the probable benefits outweigh the probable risks. Although the process may require smaller clinical trials, an HDE device must continue to operate under local IRB approval at each participating institution and must continue to collect case report forms akin to an ongoing clinical trial. The PMA process typically involves a series of studies starting with first clinical use and culminating in a multicenter, prospective randomized control trial (pivotal trial). The complexity and extent of the clinical testing program is dictated by the nature of the device and its proposed use. The clinical study program is developed by the company in conjunction with clinician investigators, all in close collaboration with FDA/CDRH.The first and arguably most important step in this process is the pre-IDE meeting, in which the company, often accompanied by the lead clinical investigator(s), meets with FDA/CDRH to present data about the device, its clinical development program, and its intended use after approval. The FDA/CDRH staff reviews existing bench and animal data (as well as any outside-the-United States clinical data) and makes informal non-binding suggestions regarding the need (if any) for additional pre-clinical data (bench and animal), as well as the study design. The sponsor then submits an IDE application to FDA/CDRH (Medical Devices) for formal review.Clinical development of a new class III device is typically divided into pilot and pivotal trial phases. The purpose of the pilot phase (starting with first clinical use) is to establish safety and to assist in design of the pivotal trial. Pilot-phase testing is typically limited to fewer than 100 patients treated at a few centers. The purpose of the pivotal trial is to generate data that define patient populations in which use of the device is safe and effective. The dialogue initiated during the pre-IDE meeting continues and intensifies between FDA/CDRH and the company over the specifics of the pivotal trial and includes the patient population, the control group against which the new device will be evaluated, and the primary and secondary end points of the evaluation. For first-in-class devices, eg, drug-eluting stents, where there are few data regarding short- or long-term outcomes, FDA/CDRH requires prospective randomized controlled studies. Though high profile, devices that require randomized data for approval are the exception rather than the rule. The vast majority of device clinical trials are case series that carefully document product performance. Still more products are approved as “tools.”Most devices currently in testing are similar to well-characterized approved devices, eg, next generation bare metal stent, angioplasty balloon, etc. When FDA/CDRH has substantial data on the device class metrics, comparisons may be made to historical data or objective performance criteria. When few data on existing standards are available, the FDA typically requires randomized rather than single-arm studies, in which the new device is compared against concurrent controls treated with current best medical practice. That comparison may be powered to show that the new treatment is superior to prior approaches, or that it is non-inferior (equivalent or better) compared with a previously approved device in a new area. The issues relating to the type of trial are discussed below.The specifics regarding study design may have profound impact on the time and cost of bringing a new device to market. Though the primary mission of the FDA/CDRH is to ensure safety and effectiveness of commercially available devices, when exerting regulatory oversight the agency must balance its primary mission with the costs of introducing new technologies to the clinical marketplace. This has been codified by the FDA Modernization Act and the FDA Modernization Act-II, which require the agency to pursue the “least burdensome means” available to establish device safety and efficacy. Although surrogate end points, eg, angiographic restenosis rather than recurrent cardiac events, may be allowed as secondary end points, the primary end point of a pivotal trial for a first-in-class class III (Classify Your Medical Device) device is usually a clinical end point (or a well-established surrogate such as infarct size in a myocardial infarction treatment device). Depending on the end points negotiated, such pivotal trials may require enrollment of 1000 or more patients at 30 to 50 sites over a period of 1 to 2 years, with appropriate follow-up frequently to 1 year after treatment. The trial must be conducted according to good clinical practices standard, with the approval of the local IRB at each participating center.Clinical Site (IRB, Contract, Conflict of Interest)Once the FDA/CDRH has approved the IDE, the sponsor must formally recruit as many as 50 sites to ensure patient enrollment in a timely fashion. Each site has its own rules regarding participation in clinical studies, which typically can be divided into 3 components: Human research, contract, and conflict of interest.Every clinical site is federally mandated to have an IRB responsible to ensure the protection of the rights, safety, and welfare of research subjects. Regulation of the IRB review of protocols involving medical devices is under the purview of the FDA. The Office of Protection From Research Risks (OPRR) is responsible for oversight regarding all human research and is in direct communication with the FDA/CDRH. Studies involving human subjects that do not involve products regulated by the FDA fall under the direct purview of the OPRR. Both the FDA and the OPRR are in the Department of Health and Human Services. Each IRB must meet standards for the composition, leadership, and processes set forth by that department. IRBs are subject to periodic audits by the FDA to ensure that records and procedures are in compliance with regulations.Working with the sponsor, the principal investigator prepares an application to the IRB at his/her institution that includes the consent form describing in lay language the device, the proposed clinical study, the inclusion and exclusion criteria for the trial, and a draft consent form describing the risks and benefits of participation in the study. The IRB then formally reviews the application and frequently requests changes, particularly to the informed consent. The IRB process typically requires approximately 3 months, but at times can take considerably longer.The company must also negotiate agreements with each clinical site addressing the many issues associated with the clinical trial. In addition to the study costs/reimbursement (per-patient enrolled and overhead), these agreements typically include indemnification and the assignment of ownership rights of new discoveries (intellectual property) made in the course of the study. The resources required at each center to perform the high quality research necessary for a PMA protocol are formidable. In addition to resources required to maintain an excellent clinical program (physician, nursing, and technical staff coupled with state of the art facility), the study center must dedicate additional resource, primarily research nurses to perform high-quality clinical research. The role of the research nurse is critical to all phases of the trial, including general study management, IRB process, patient recruitment, and accurate completion of case report forms. The sponsor is responsible for accrediting each clinical site to document that the necessary resources are in place to fulfill the demands set forward in the protocol. The clinical research staff do not provide clinical care and are thus not part of the hospital’s salaried clinical nursing staff. The per-patient costs include all additional charges the patient incurs for the study, including procedures (therapeutic and diagnostic), clinic visits, and diagnostic studies, as well as research nurses’ salaries. It is estimated that it takes 3 to 6 months to formally recruit each clinical site.Device development from the earliest stages requires active involvement of practicing clinicians. Clinician/inventors are frequently involved in creation of the device concept and are often integral members of the design team performing the majority of the early animal studies. Through this involvement, the clinician/inventor obtains intimate knowledge of device performance and failure modes. Safety concerns during first clinical use and pilot phase mandate participation by these clinician/inventors. The clinician/inventors frequently take leadership roles and have equity positions in the company developing the device. These interests present important conflicts of interest which must be addressed to ensure patient safety, data integrity, and public trust in the process. Many institutions have set up formal processes to address these conflicts of interest, potentially adding more time to the institutional recruitment process.Pivotal studies required for a PMA application are typically large multicenter randomized trials and often represent the largest commercial risk and expense in the device development process. In addition to obtaining an IDE from the FDA and formally recruiting clinical sites, the sponsor must also put into place an extensive infrastructure that typically includes engaging a contract research organization (CRO), core laboratories, formation of a data safety monitoring board (DSMB), and an executive committee. The CRO provides the infrastructure required to recruit, qualify, and audit sites. Core laboratories evaluate primary data, eg, angiography, ECG, and ultrasound results, in a uniform and blinded manner. An executive committee is typically composed of the clinician investigators, company representative, CRO, and core laboratories. The DSMB, composed of a group senior clinical investigators and statisticians with no other involvement in the study, periodically reviews trial data at specified intervals. The DSMB has the mandate to stop or modify a study, eg, discontinue randomization to one of the groups if complications associated with the study device are in excess of anticipated rates, if differences between study groups reach statistical significance, or if further patient enrollment will not impact study outcome.Regulatory Approval Process (European Union)Though there are many similarities in the regulatory process in the United States and countries within the European Union, there are important differences that impact the time and cost associated with the introduction of a new medical device.I have identified 3 illustrative examples: Use of notified bodies, criteria for approval, and local site (IRB/site negotiation).The European Union system relies heavily on notified bodies (NBs), which are independent commercial organizations to implement regulatory control over medical devices. NBs have the ability to issue the CE mark, the official marking required for certain medical devices. NBs are designated, monitored, and audited by the relevant member states via the national competent authorities. Many functions performed by the FDA/CDRH within the United States are performed by NBs, including medical device certification, device type designation, assessment and verification of quality systems, and review of design dossiers for high-risk devices. Currently, there are more than 50 active NBs within Europe. A company is free to choose any notified body designated to cover the particular class of device under review. After approval, post-market surveillance functions are the responsibility of the member state via the competent authority. NBs typically function in a closed manner, providing little visibility on criteria required for approval. This dynamic allows for a high degree of variation as well as competition among NBs. As a result, NBs are perceived by industry to be less bureaucratic organizations that can respond more quickly and efficiently than the FDA. These potential benefits may be offset by a system that is intrinsically more fragmented and highly variable and has resulted in the approval and continued marketing of devices, eg, abdominal aorta stent grafts, in Europe that failed efficacy trials in the United States.Criteria for approval of high-risk devices are different in the European Union. To receive approval to market a class III high-risk (and some class II) device in the United States, the manufacturer must demonstrate the device to be reasonably safe and effective, which typically requires a prospective, randomized controlled clinical trial. To receive approval to market a device in the European Union, the manufacturer must demonstrate that the device is safe and that it performs in a manner consistent with the manufacturer’s intended use. This difference has a profound impact on the size and scope of the clinical studies for regulatory approval. This significant difference is illustrated by examining the introduction of distal protection systems. The GuardWire developed by PercuSurge, Inc (later acquired by Medtronic) is a specialized coronary guidewire with an elastomeric balloon mounted at the tip. During an angioplasty/stent procedure, the operator crosses the lesion with the GuardWire and inflates the balloon. Stent placement is then performed, after which a specialized catheter is used to evacuate any arterial debris that may have become dislodged during the procedure. The GuardWire balloon is then deflated. Demonstration of safety and performance, ie, ability to aspirate material during the stenting procedure, was demonstrated in a 22-patient single-arm study. In contrast, in the United States, this device was designated class II (requiring 501[k] clearance and clinical data). To satisfy US criteria for clearance, the standard of safety and effectiveness required in this case was defined as the ability to reduce complications associated with stenting of saphenous vein grafts. To meet this criterion, an 800-patient multicenter trial randomized trial comparing distal protection to usual care (no protection) was performed. At 30 days, a 42% relative reduction in major adverse cardiac events (primarily myocardial infarction) was observed. A trial of this type is estimated to cost US$10 to $12 million and may take 24 months to perform.

No question the viewpoint of Mason, that Prophets of the Church of Jesus Christ of Latter Day Saints are fallible, is correct. They are human. They make mistakes. Their mistakes are not just in everyday temporal affairs, but in policy, program and administration as they attempt to lead the Church of Jesus Christ LDS. Prophets making mistakes are not unusual upon review of the Bible as well as the restored Church. Joseph Smith himself taught that ‘a prophet was a prophet only when he was acting as such’.Often people assume all statements from Prophets are equal. They are not. To members and critics of the Church of Jesus Christ of Latter Day Saints, the problem is often differentiating between: i) Scripture; ii) Doctrine; iii) Official Direction; iv) general admonition or suggestion; v) insight for a specific situation; vi) expression of personal opinion from Mormon Leaders. Failure to discriminate between these exacerbates confusion regarding both the Gospel and the Church. Too often opinion is given the same weight as Scripture, Doctrine or Official Direction. Opinions, no matter the source, are neither Doctrine nor Binding on the Saints.1.A few basics regarding the communications of LDS Church leaders. One must be very cautious in determining what is commandment or doctrine; inspired opinion or admonition; personal ideas that may even be incorrect. Satan and his hosts love to confuse these elements and have folks shift focus from the forest to an individual leaf on a specific tree, or even individual leaves on several specific trees. Lucifer then uses, often inaccurate conclusions regarding these few specific leaves, to dismiss the value of the entire forest. Use of revealed, consistent, patterns, confirmed by personal spiritual proving will help each of us determine what is Doctrinal truth rather than opinion, admonition or attempts to clarify, illustrate or simplify complex concepts.a.Critics and members alike forget or ignore Joseph Smith’s basic tenet that ““A prophet is a prophet, only when he [is] acting as such.” (February 1843; DHC 5:265) As if to emphasize this, shortly before his martyrdom Joseph Smith said “I never told you I was perfect- but there is no error in the revelations which I have taught.” (The Words of Joseph Smith; Ed. Ehat & Cook; Religious Studies Center, Provo, Utah; 1980; pg. 369)b.Some ideas of different LDS leaders, which were stated as opinion, are quoted by members and non-members as doctrine, when in reality; those things are not and never were doctrinal.i.For example, Doctrine about the LDS Church containing the fullness of the Gospel and being the only Church with Priesthood Authority, is sometimes erroneously expanded and generalized by LDS faithful to discount, disparage, minimize and trivialize the valid faith, good works, gifts of the spirit, etc. enjoyed by differing believer’s. The same type error is often made by non-LDS critics who use an LDS leader’s off-hand comment to discount, disparage and Trivialize the Gospel and The LDS Church.ii.Consider, President Hinckley did not correct Mike Wallace during a nationally televised interview when, in a long list of items, Wallace erroneously stated the LDS Church prohibited caffeinated beverages. Immediately some members and non-members expanded the Word of Wisdom to include Coke and Pepsi. President Hinckley did not correct Mr. Wallace on this and a number of other minor points on which Mr. Wallace erred. President Hinckley was addressing far broader issues and audiences and spending any of an extremely limited time on a minor correction would have been wasteful at best and created an adversarial reaction at worst. President Hinckley was inspired, as the Apostle Paul was inspired, when instead of correcting, Paul in Athens at Mars Hill used a statue of the “Unknown God” (Acts 17:23) to facilitate teaching of greater truths.Everyone, especially LDS faithful, should know expansion of Doctrine will not occur during an interview on “60 Minutes”. The Word of Wisdom as revealed and clarified by Official Written Statements from the First Presidency and the Twelve is represented by the Temple Recommend Questions, which do not address caffeinated beverages. However, that does not dissuade critics from fault finding or establishing new Doctrine where no fault was intended nor new Doctrine ever existed.b.LDS critics often conclude if there is a problem with anything any Prophet or Apostle says or does in any arena, then nothing they or any of their colleagues say can be considered truth. Goodness sakes alive, given that test Peter, James, John and the other Apostles contemporary with Judas Iscariot would all have to be discounted both for their personal human actions and guilt by association. Critics often use nuances of this approach citing a General Authority LDS Stake Conference talk, a poor personal investment, an instance of temper or an interview by an LDS General Authority as evidence of unworthiness or an official statement of Doctrine. The mistake of inappropriate and inaccurate generalization is the same as possible criticisms of Christ’s Apostles during and after his earthly ministry.2.Various categories of communication from God to His leaders and their suggested application by LDS faithful.a.All LDS Canonized Scripture is Doctrine and consists of teachings or policies presented after approval of the Quorum of the Twelve and the First Presidency, then accepted by vote of the membership and published as part of LDS Canonized Scripture. Thus the Doctrine and Scripture consists of declarations, proclamations, manifestos, revelations, etc. which are formally canonized through the aforementioned process. These are binding on LDS membership. As the LDS faithful accept the reality of ongoing revelation, there may be changes, additions, etc. These are very rare and the change or addition, excepting spelling and grammar corrections, must follow the same process of approval of the First Presidency, the Twelve and vote of the membership before becoming canonized.b.Official communications, proclamations, statements, letters, etc. when approved by formal vote or signature by both the First Presidency and Quorum of the Twelve and publicly introduced at General Conference or in another formal setting or format are also considered at the same level as Doctrine and should be accepted as official and binding, but are not canonized Scripture. These, whether they address principle, precept or administrative direction are binding on the LDS membership if so stated in their content. As the LDS faithful accept ongoing revelation to direct the church, there may be changes in these, but such are very rare.c.Communications formally signed by the First Presidency are considered binding and should be accepted as official, although these are often policy or statements regarding specific issues which can be amended as directed by the Lord.d.Communications formally signed by the Twelve which are in harmony with the concepts above are considered binding and should be accepted as official, although these are often policy or statements regarding specific issues which can be amended as directed by the Lord.e.Official LDS books, manuals, handbooks, published under written authority of the First Presidency and or the Twelve should be accepted as official. These are often policy or approaches to implementation of Doctrinal Precepts which can be amended as directed by the Lord.(Note: Many critics do not even attempt to accurately portray these for what they are…usually administrative or teaching tools with specific incremental applications within a particular context.)f.First Presidency Messages contained in the Ensign and other publications 10 of the 12 months each year are designed to inspire, motivate and personalize elements of the gospel or church. The basis of these is Scripture, Doctrine or official church programs. However, the illustrations, examples, stories, contemporary facts, suggestions for application, humor, personal extrapolation by the readers, etc. are not Scripture, Doctrine or official programs.g.General Conference talks are usually developed to foster understanding and application of Scripture, Doctrine or official programs. These talks may be based on scripture and use the teachings of Prophets, Apostles, secular sources and other devices to help illustrate and enlighten. The basis of these is Scripture, Doctrine or official church programs. However, the illustrations, examples, stories, contemporary facts, suggestions for application such as “ponderize”, humor, personal extrapolation by the message recipients, etc. are not Scripture, Doctrine or official programs. These are admonitions, encouragement, communication devices, insights, etc. designed to assist understanding and motivate commitment. As they do not rise to the level of Doctrine or Scripture, attacks on these are irrelevant to the LDS Church or the LDS Doctrine. (Note: Critics often attack elements of these communications as if they were central LDS doctrine. That is like attacking the quality of milk based on the design of the logo or color of the container.)h.An informal approach through which truth and light is received and shared by Church Leaders. Truth when taught by the Spirit and received by the Spirit on an individual level can be affirmed as truth, without canonization or having the specific signed and publically affirmed declarations and other methodology described above. Often events such as personal visits or interaction with leaders, personal blessings received from leaders, as well as specific instructions to specific groups in specific settings, fit into this very valid and powerful category.i.Validity of such Personal Revelation described above by leaders or members is confirmed by presence of all the following elements:1.Being in harmony with and not in contradiction to Canonized Scripture or Official pronouncements outlined above, which authoritatively convey true doctrine; (Note: Valid personal revelation will not include anything that contradicts, minimizes or alters basic doctrines such as: the necessity for and redeeming power of the Atonement; The eternal nature of matter/energy, both physical and spiritual as well as intelligence; purpose of this mortal sphere; the Law of Eternal Progression; the composition and eternal nature of families; the importance of free agency; Christ physically was the literal Son of the eternal God and Jesus’ mortal mother, Mary [Cautionary Note : The Encyclopedia of Mormonism states: “ Latter-day Saints believe that the eldest and firstborn spirit child of God [the Father Elohim and his eternal wife, our Heavenly Mother] is Jehovah and that it was He who was later born with [His firstborn eternal sprit inhabited] a physical body to mary as Jesus Christ. It is LDS doctrine that Jesus Christ [physical body] is the child of mary and God the Father [Elohim], ‘not in violation of natural law but in accordance with a higher manifestation thereof’". Though speculation abounds ranging from invitro processes to physical contact, the specifics of this process have never been revealed and definitive statements by any are to be taken as opinion.]; the necessity of opposition to enable choice; the love of our Father in Heaven for each one of us, his literal spirit children; etc.)2.Consistent, continuous, long term, affirmation by Prophets and Apostles (not just an isolated single quote);3.No open expression of alternatives or disagreement among Prophets and Apostles;4.Widespread, frequent, consistent and regular repetition of the specific concept by more than one of the Prophets and Apostles;5.The universal applicability of the concept;6.Personal validation using the Spiritual Method (discussed earlier in this work);7.Possible eventual inclusion in Handbooks, Manuals, etc. provided it fits within the parameters of such publications.ii.Some things that do not fit these guidelines: “Moon Men”; exact geographic locations of Book of Mormon events (open discussion on this continues); the Adam/God theory; explanations regarding why Blacks were not ordained to the Priesthood for a significant time (there were always a variety of reasons advanced and disagreement by different LDS leaders); Man will not set foot on the Moon (although technically accurate as those who did “moon-walk” were insulated and isolated in suits and boots that provided an earthly internal setting…so man’s foot was not literally on the moon…but who is even going to bother with arguing that point as it fails in all seven of the earlier mentioned criteria?); The exact interface between and structure of government and churches including the LDS Church during The Millennium; Moroni dedicating the site of the Manti Temple; Most accounts of ministering of the Apostle John, the Three Nephites; Pictures of Joseph Smith using the Urim and Thummim; etc. (Note: These are the type of targets which critics most frequently use to create controversy. Many critics consistently, mistakenly or intentionally, misrepresent what these targets in reality are and what they mean. They often self-righteously fire away at “strawmen” of their own creation. In so doing they frequently, at best, inaccurately represent what is contained therein. Many critics do not even attempt to accurately portray these concepts in precept, yet alone the inferred application of such. These are often blatant attempts to deceive, exemplary of “Yellow Journalism”, fraudulent “shoddy scholarship” and egregious, knowing, dishonesty.)iii.Some things that do fit these guidelines, some of which were introduced in talks or journals and later have been included in manuals, official declarations or even canonized scripture: Every Member a Missionary; Lorenzo Snow’s vision of the Savior in the Salt Lake Temple; the lineage of Israel being present throughout the South Pacific Islands; Lorenzo Snow’s Doctrinal summary of Joseph Smith’s King Follett Discourse “As man is, God once was; As God is, man may become”; Three Fold Mission of the Church; “A Prophet is only a Prophet when acting as a Prophet”; The Savior opened Missionary Work in Spirit Prison was accepted in this way until canonized in the Doctrine and Covenants; the Block meeting schedule first suggested in 1920 by David O. Mckay; Official Declarations 1 and 2 in the Doctrine and Covenants which canonized as Doctrine specific positions; etc.i.Other speeches or writings from any Church Authorities, including communications in Church Publications, Firesides, Social Media Accounts, books published by Deseret Book, etc. are, with rare exception, considered to be admonition, counsel or opinion designed to enlighten, lift, encourage or stimulate thinking and personal soul searching. Generally, these only reach the level of Official Doctrine when distributed under the signature of the First Presidency, The Twelve or both as stated above.(Note: Critics often fire away at this target although, most do not even attempt to accurately portray these for what they are…usually admonition, counsel or opinion with limited applications within a specific context. Critics treat statements, often out of context, from these sources as if they were Doctrine or Official Church Positions. They are official only to the extent they meet the guidelines outlined above.)These communications rise to Doctrine only provided they meet certain requirements outlined below. (Note: Many critics very seldom even examine these qualifying criteria. They blather on as if everything communicated was Doctrine or Official Policy when few things ever meet the criteria outlined below.)When holy men of God write or speak by the power of the Holy Ghost, their words “shall be scripture, shall be the will of the Lord, shall be the mind of the Lord, shall be the word of the Lord, shall be the voice of the Lord, and the power of God unto salvation” (D&C 68:4). Most of these requirements are clearly outlined in the Booklet “True to the Faith” available online through the LDS “Gospel Library” app. Statements or writings meeting the following criteria are to be considered in the same light as Doctrine in the specific setting they are shared. Validation requirements to reach the level of Official Doctrine include all of the following:i.An essential element is these statements or writings serve the principal purpose of such inspired communications, “to testify of Christ and to guide the children of God so they can come unto Him and receive eternal life” (see John 5:39; 20:31; 1 Nephi 6:4; Mosiah 13:33-35). The principal purpose of scriptures (including inspired speech, writings or videos) …must be…to testify of Christ and to guide the children of God so they can come unto Him and receive eternal life (see John 5:39; 20:31; 1 Nephi 6:4; Mosiah 13:33-35).ii.Those teachings are delivered “by the power of the Holy Ghost”. As these are things of the spirit they must be understood by the Spirit in the context in which where they are presented;iii.A key element is these types of teachings are taken in the context of and are not in conflict with canonized scripture, official proclamations, etc. as outlined above;iv.The teachings should further, be congruent with and supportive of Scripture, Doctrine, official statements, etc.v.Cautions about these communications include:1.A broader Church Wide application of such teaching beyond a specific setting usually will be promulgated officially under the Signature of the First Presidency, The Twelve or both.2.A broader personal application of such teachings beyond a specific setting must be carefully developed and spiritually confirmed.a.For example, suggestions based on Doctrine or Scripture regarding how to better study the scriptures are not intended to be commandments dictating how to examine all scriptures in all cases; rather helpful suggestions.b.Comments regarding a particular event, contemporary issue, specific challenge, etc. are not intended to be new Doctrine or commandments; rather helpful suggestions, illustrations or examples of greater issues or even just personal observations.j.All other communications, from the First Presidency or the Twelve, individually or collectively; other General Authorities; General Officers of Church Auxiliaries (Relief Society, Sunday School, etc.); LDS experts such as BYU Faculty and Administration, LDS Institute, Seminary, other knowledgeable sources; Area and Local leaders: etc. which do not fall within the above categories (7. a – i).i.For example: seasonal messages; observations regarding current events; welcomes for guests, conventions, businesses; comments at business or civic events, etc.; social media messaging; Tweets; Posts; personal letters; convention speeches; statements made during interviews; devotional talks (even at BYU); specialized training events; articles, even in Church publications such as Church News; General Conference addresses; Stake Conference talks (even Saturday night sessions); books and pamphlets; Fireside comments; etc. (One example of this was Bruce R. McConkie’s first edition of “Mormon Doctrine” which strongly stated many personal opinions and Elder McConkie, at the urging of his “General Authority Brethren” developed a second edition with numerous changes and corrections.)ii.Should be received as: counsel; advice; guidance; admonition; insight; civil/social hospitable communication; etc. to be applied individually by church members as the spirit directs, within the context where they are delivered. These communications are not broadly applicable as are Scriptures or Formal Doctrine. They are not mandates except for portions where they directly quote or refer to Scripture or Formal Doctrine.iii.The vast majority of these other forms of communication are grounded in and congruent with concepts of civil/social hospitable communication, the canonized scripture and its outgrowths related to longstanding practice and traditional policy. However, no matter whom the originator, if communications are not within the guidelines for Scripture, Doctrine or Official Church Policy, they are not considered official LDS Church Policy or Doctrine and are neither binding nor broadly applicable. They should be used cautiously and correlated carefully with the Scriptures, Official Doctrine and personal spiritual effort.(Note: Critics often fire away at this type of target although, many do not even attempt to accurately portray these for what they are…usually admonition, counsel, opinion or civil/social hospitable communication, with specific applications within a specific context. Numerous critics treat statements, often out of context, from these sources as if they were Doctrine or Official Church Positions. They are usually neither.)k.Opinions, written and verbal; books; pamphlets; recordings; other speeches; etc. such as Brigham Young’s statements about moon dwellers, Ezra Taft Benson’s conclusions about the John Birch Society, Thomas Monson’s admonition “Let’s go shopping”, etc. are neither doctrine nor scripture nor do they pretend to be. Often such statements have little or nothing to do with bringing people to the Savior or testifying of his mission. They may be interesting, helpful as counsel in a specific situation; useful to provide insight; amusing or helpful to illustrate a concept; civil/social hospitable communication; etc. but that is all.(Note: Critics often fire away at this target although, many do not even attempt to accurately portray these for what they are…usually opinion, admonition, humor, or counsel, used to illustrate a concept with specific applications within a specific context. Many critics treat statements, often out of context, from these sources as if they were Doctrine or Official Church Positions. They are almost always neither.)l.Ultimately, the Spiritual Method of proving truth personally should be always applied. After all the intellectual research and study has been completed; consistencies have been analyzed; the concepts have been applied; only the Lord can confirm His truth through the power of the Holy Ghost so as to remove all doubt. One seldom needs to rush into resolution of questions. Work the process the Lord has provided and prove these things to yourself.m.Note of Caution…In addressing this topic J. Ruben Clark Jr. who spent 28 years as a member of the LDS First Presidency stated: “There have been rare occasions when even the President of the Church in his preaching and teaching has not been "moved upon by the Holy Ghost." You will recall the Prophet Joseph declared that a prophet is not always a prophet.To this point runs a simple story my (J Ruben Clark’s) father told me as a boy, I do not know on what authority, but it illustrates the point. His story was that during the excitement incident to the coming of Johnson's [sic] Army, Brother Brigham preached to the people in a morning meeting a sermon vibrant with defiance to the approaching army, and declaring an intention to oppose and drive them back. In the afternoon meeting he arose and said that Brigham Young had been talking in the morning, but the Lord was going to talk now. He then delivered an address, the tempo of which was the opposite from the morning talk.I do not know if this ever happened, but I say it illustrates a principle—that even the President of the Church, himself, may not always be "moved upon by the Holy Ghost," when he addresses the people. This has happened about matters of doctrine (usually of a highly speculative character) where subsequent Presidents of the Church and the peoples themselves have felt that in declaring the doctrine, the announcer was not "moved upon by the Holy Ghost." (Useful Sources 24!!!)I appreciate this story from President Clark who served so long (28 Years) in the First Presidency of the Church… “If one in church authority makes an error in substituting personal opinion as doctrine regarding anything of eternal substance, it will be corrected.ConclusionThere is also more subtle change in the prevalence of powerful personal opinion which often seems to occur. I note in particular after being sustained as the Prophet, several LDS Church Presidents seemed to immediately “Mellow”. Joseph Fielding Smith seemed to many members to have a changed, more mild, loving demeanor immediately after his calling. After being sustained, Ezra Taft Benson, the erstwhile champion of the John Birch Society, seldom even addressed political issues in passing, yet alone making major public pronouncements. In the Biography of Gordon B. Hinckley no less an authority than his wife, Marjorie, made this observation. “I have known this man since high school and I have never known him to say anything or do anything that would not be appropriate for an Apostle. But he is a different man now than he was when he was ordained President of the Church. I know this embarrasses him and I will probably get scolded when I get home, but I know he is a prophet of God. I have seen the power of God magnify him. I have seen him solve problems that seemed to be almost unsolvable because the Lord has given him the inspiration and answers to move the work along. I remember that his is almost, but not quite perfect-but more importantly, he bears the mantle of Prophet”.There is a great and comforting lesson regarding how the Lord works thorough his servants as we examine their growth and change of focus during their service. The Lord will also help us grow in this same way as we dedicate ourselves to His service. We can come to the point we are in tune with the spirit and live and speak according to divine directive and truth. In fact even the Old Testament Prophet Moses encouraged this in response to being informed of some prophesying during a spiritual experience of seventy elders when he said “… Enviest thou for my sake? Would God that all the Lord’s people were prophets, and that the Lord would put his spirit upon them!” (Numbers 11: 25 – 29) Ultimately this oneness and understanding is exhibited perfectly between the members of the Godhead and Christ encouraged his followers to also become one in the same manner. John 17:21 teaches Christ prayed to His Father in Heaven requesting “…That they may all be one; as thou, Father, art in me, and I in thee, that they also may be one in us:…”(Note: Few critics ever care enough to even seek to understand this process. Most are so busy trying to throw rocks and break the glass they miss the beauty of the view from the picture window.)