- FDA on Monday published final guidance updating procedures for reviewing requests for recognition of voluntary consensus standards for medical devices and when withdrawing recognition of a previously recognized standard.
- Voluntary consensus standards in general have been used for decades by device makers to meet premarket submission requirements. FDA's new text revises procedures laid out in 2007 for evaluating consensus standards and is related to a 2018 guidance defining appropriate use in premarket device submissions.
- FDA plans to hold a webinar on Oct. 15 for the device industry and other stakeholders to discuss and take questions on the latest guidance.
FDA believes use of voluntary consensus standards can help streamline the premarket review process for medical devices, increase predictability and promote international harmonization. The consensus approach is applied to processes involved in evaluating device safety and effectiveness, such as testing methods, acceptance criteria and risk management.
The 2018 guidance on appropriate uses for consensus standards received some industry pushback, when proposed four years earlier, due to the agency's resistance to the use of promissory statements by companies in many cases. FDA in the final guidance said it expects conformance to a consensus standard before submission of a premarket application.
In the new guidance, FDA addresses how to request recognition of a consensus standard, decisions on complete or partial recognition of a standard, and how it arrives at non-recognition when a standard does not satisfy regulations. It may also withdraw recognition of a previously recognized standard, when that standard is replaced by a new version, or when the standard is no longer appropriate for meeting a requirement.
The agency said it considers standards developed in adherence with the American National Standards Institute Essential Requirements and may also recognize standards developed in the private sector by professional societies, industry associations and other organizations such as the U.S. Pharmacopeia Convention. Voluntary consensus standard bodies such as the International Electrotechnical Commission, International Organization for Standardization, Institute of Electrical and Electronics Engineers, and ASTM International usually develop standards that meet U.S. criteria, FDA said.
FDA said it intends to respond to recognition requests within 60 days and will publish its justification for recognition and non-recognition decisions. The agency also plans to periodically update its Recognized Standards Database with pending recognitions. As soon as a recognition appears in the database, manufacturers may cite it in premarket submissions without waiting for the publication of a Federal Register notice.