FDA Updates Guidance on Voluntary Consensus Standards


Posted September 18, 2018

The Food and Drug Administration (FDA) has issued two guidance documents updating how the agency approaches voluntary consensus standards, one on their use for premarket evaluation of medical devices and the second on how standards are recognized and withdrawn. The first document is final guidance from the FDA, and the second was issued in draft form.

“The use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products,” the FDA wrote in its final guidance. “The use of consensus standards can also promote international harmonization. For decades, FDA has supported and relied on the development and use of consensus standards to support the agency’s mission in protecting and promoting the public health.”

The final guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, seeks to clarify how industry can use Declarations of Conformity to FDA-recognized standards in their premarket submissions.

“Standards are particularly useful when an FDA-recognized consensus standard exists that serves as a complete performance standard for a specific medical device. Conformity with other more general (i.e., device-specific standards that may not encompass all aspects of device performance) can also streamline the premarket review process,” the FDA wrote on its website.

The final guidance details when the use of standards is appropriate for a premarket submission (via a Declaration of Conformity or for “general use”)—and what information is needed to support the submission. According to the final guidance, premarket submissions sometimes lean on standards that have not been recognized by the FDA or have not been FDA recognized for all aspects of the submission. The guidance includes a table and information to help manufacturers determine when they can use Declarations of Conformity, and when additional data is needed.

“The final guidance on the use of standards for premarket submissions adds needed clarity to how standards can be used, both with Declarations of Conformity and otherwise to support submissions to the FDA for device approvals,” said Jennifer Padberg, senior vice president of standards program and policy at AAMI. “Ultimately, that helps facilitate safety and efficacy in medical device development.”

Notably, the final guidance updates how standards are accepted into the FDA’s standards recognition database. Previously, standards first had to be published in the Federal Register, which the FDA typically updates for standards twice each year. Under the new final guidance, the FDA will indicate when a standard is targeted for recognition in its online database once that decision is made.  Companies can then begin using the standard immediately and will not have to wait for publication of the formal Federal Register notice.

The final guidance also establishes a transition period when previously recognized standards are undergoing replacement, intended to “decrease the burden of implementing a shift from one version of a consensus standard to a newer version,” the FDA wrote. “By providing transition periods, FDA enables the submitter to continue current product development and testing potentially without having to conduct additional testing due to a newer version of a consensus standard having been published and recognized.”

During such a transition period, the previous standard may be used, but justification for using the older version should be provided “when a newer version of the standard raises significant questions that were not previously addressed,” the FDA wrote.

The separate  FDA draft guidance, Recognition and Withdrawal of Voluntary Consensus Standards, updates how the agency recognizes standards. The draft guidance details how “any interested party” can nominate a standard for recognition by the FDA. The process can be completed via mail or email.

“The new draft guidance on the recognition and withdrawal of voluntary consensus standards is also helpful in explaining how outside parties can propose new standards for recognition by the FDA, and how those standards will be evaluated,” Padberg said. “Both the new final guidance and the draft guidance demonstrate the essential role that standards play in promoting medical device safety and effectiveness.”

Comments on the draft guidance can be submitted via www.regulations.gov until Nov. 13. The FDA accepts feedback on final guidance documents at www.regulations.gov on an ongoing basis.