On September 14, 2018, FDA issued two new guidance documents on voluntary consensus standards used in medical device premarket submissions: (1) a draft guidance titled “Recognition and Withdrawal of Voluntary Consensus Standards” (Draft Guidance); and (2) a final guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” (Final Guidance).
Voluntary consensus standards are standards developed by voluntary consensus standards bodies, such as the International Organization for Standardization (ISO) or the International Electrotechnical Commission (IEC). The Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. No. 105-115) and the 21st Century Cures Act of 2016 (Pub. L. No. 114-255) amended section 514(c) of the Federal Food, Drug, and Cosmetic Act (FDC Act), requiring FDA recognition of voluntary consensus standards.
The purpose of FDA’s formal recognition of consensus standards is to streamline the premarket review process for medical devices. FDA-recognized consensus standards are standards that FDA has vetted and determined are appropriate to support clearance or approval of a device. This formal recognition allows companies to submit a declaration of conformity with a recognized standard in a premarket application, rather than submit complete data and test reports demonstrating conformity with a standard.
These guidance documents consolidate and supersede earlier guidance documents on the topic of voluntary consensus standards. The Draft Guidance, when final, will supersede a document titled “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition,” issued in September 2007. The Final Guidance supersedes three earlier guidance documents: “Recognition and Use of Consensus Standards” (issued in September 2007), “Frequently Asked Questions on Recognition of Consensus Standards” (issued in September 2007), and “Use of Standards in Substantial Equivalence Determinations” (issued in March 2000).
The Draft Guidance describes FDA’s process for choosing to recognize voluntary consensus standards and to withdraw recognition of standards.
The 2007 document the Draft Guidance is intended to replace, “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition,” is more akin to an internal FDA procedure, even though it is labeled as “Guidance for Industry.” The 2007 document described FDA’s internal workflow for identifying standards for recognition and reviewing proposals by outside persons for FDA recognition.
The Draft Guidance shifts the focus, addressing FDA’s recognition and withdrawal processes from the perspective of industry. It is largely simplified compared to the 2007 document, and describes industry’s interaction with FDA regarding FDA-recognized consensus standards.
The Draft Guidance outlines the process for requesting recognition of a standard. It lists certain elements required to be included in a request for recognition, such as the title of the standard, a proposed list of devices for which a declaration of conformity should routinely apply, and identification of the testing, performance, or other characteristics of the device that would be addressed by the declaration of conformity.
Notably, the list of required elements in the Draft Guidance includes a “basis for recognition, e.g., including the scientific, technical, regulatory, or other basis for such request.” The 2007 document does not require requests for recognition to include an explanation of the basis for the request.
The Draft Guidance notes that when FDA receives a request for recognition of a standard, it will send an acknowledgment letter to the requester. The letter will identify a contact person at FDA who is assigned to oversee the recognition request. As FDA conducts its assessment of the recognition request, it may contact the requester for clarification or additional information about the request. The 2007 document, in contrast, did not describe any mechanism for follow-up or additional communication with the Agency about a request.
The Draft Guidance states that FDA’s goal is to issue a decision of complete recognition, partial recognition, or non-recognition no later than 60 calendar days after a request is received. The Agency will then issue a decision letter to the requester and announce decisions to recognize a standard in the Federal Register. The list of recognized consensus standards is also reflected in FDA’s online database: Recognized Consensus Standards.
The Draft Guidance explains that there are two “primary situations” where FDA may decide to withdraw recognition of a standard: (1) when a new edition of the standard is issued; and (2) when FDA determines that the recognized standard is “no longer appropriate for meeting a requirement regarding devices” (as stated in section 514(c)(2) of the FDC Act). The Draft Guidance does not provide any detail about the criteria FDA may use to determine when a recognized standard is “no longer appropriate.”
The Final Guidance describes appropriate use of voluntary consensus standards in device premarket submissions, largely consolidating the information in the three superseded guidances. It describes the appropriate use of both FDA-recognized and non-recognized consensus standards in device premarket submissions.
The guidance outlines two appropriate uses for voluntary consensus standards in premarket submissions: (1) submission of a declaration of conformity (DOC) and (2) “general use” of the standard. A DOC may only be submitted for FDA-recognized standards. “General use” of a consensus standard refers to “situations where a submitter chooses to conform to a consensus standard, in part or in whole, but does not submit a DOC.”
The guidance lists the required elements of a DOC. The list of required elements is shortened compared to list in the superseded guidance, “Recognition and Use of Consensus Standards.” It only requires a statement of conformity with the standard and information about the sponsor, standard, and device. The list of required DOC elements also includes information about any limitation on the validity of the DOC, such as how long the declaration is valid, what was tested, and/or concessions made about testing outcomes.
The superseded guidance included in its list of required DOC elements descriptions of alternative testing performed, inapplicable portions of the standard, and deviations from the standard. The Final Guidance does not include these elements in its list of required DOC elements.
The Final Guidance states: “A DOC to a consensus standard may be used when a submitter certifies that its device conforms to all of the requirements of a consensus standard that FDA has recognized . . . . In a DOC, the submitter may not deviate from the consensus standard that FDA has recognized or decided to recognize.” This seems to indicate a change in approach from the superseded guidance, in that a DOC is no longer appropriate if there are any deviations from the standard, whereas under the previous guidance such deviations could be included in the DOC itself.
The Final Guidance includes a helpful chart outlining when a sponsor should submit supplemental information with a DOC, such as a summary of acceptance criteria, results, or a complete test report. Generally, the guidance indicates that supplemental information is necessary when the standard does not include specific acceptance criteria or when the standard is too general or broad in scope for FDA to determine whether conformance to the standard is sufficient support to make a regulatory decision. The guidance provides ISO 14971 (Medical devices – Application of risk management to medical devices) as an example of a consensus standard that would require submission of supplementary information, because this standard is broad in scope, process-oriented, and does not include specific acceptance criteria.
The Final Guidance explains that “general use” of a consensus standard, instead of submission of a DOC, is appropriate when FDA has not recognized a standard or the submitter deviates from a recognized standard. FDA recommends that sponsors, when citing general use of a standard, include the basis for the use of the standard, along with the underlying data and documentation that supports conformance with the standard. The guidance does not provide any information about the utility of citing general use of a standard in a premarket submission, given that a sponsor would cite general use of a standard in situations where FDA has not recognized a standard or the sponsor has deviated from a recognized standard.
The Final Guidance describes the transition period when FDA has withdrawn an older consensus standard that has been replaced with a new edition. This is a common issue that sponsors face while drafting device premarket submissions. The guidance explains that FDA’s online recognized consensus standard database includes a “Supplemental Information Sheet” (SIS) for each recognized standard. In situations where a recognized standard is replacing an earlier recognized standard, the SIS will include information about the transition period. If a transition period expires before submission, a sponsor will need to retest to the new standard prior to submission. The guidance notes that if a standard changes during active review of a premarket submission, the Agency will continue to review the submission based on the previously recognized standard. Similarly, if a standard changes after clearance, the sponsor will not have to retest to the new standard.
The Final Guidance describes the use of promissory statements (i.e., a statement in which a sponsor indicates that it is not yet known whether a device conforms to a consensus standard, but that the device will conform to the standard prior to marketing). FDA indicates in the guidance that promissory statements are usually not appropriate to support a premarket submission, and a promissory statement cannot be submitted along with a DOC.
Finally, the Final Guidance discusses the limitations of consensus standards. The guidance cautions that a device may raise issues not addressed by consensus standards. A premarket submission may require animal or clinical studies, additional performance specifications, and other additional information to support clearance or approval, even if it conforms to relevant consensus standards.
The new Draft Guidance and Final Guidance provide condensed and consolidated information about voluntary consensus standards. These two guidances cover the two major areas where industry interacts with the Agency on the topic of voluntary consensus standards: requests for recognition of standards and use of standards in premarket submissions. At the very least, sponsors will likely be grateful that they can find the key information about voluntary consensus standards in two guidance documents that was originally spread across four separate guidances.