AAMI News October 2018

FDA Updates Guidance on Voluntary Consensus Standards

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one on their use for premarket evaluation of medical devices and the second on how standards are recognized and withdrawn.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.

Jennifer Padberg“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.”

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

“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 publish a list of recognized standards in its online database—and make them available—right away.

The final guidance also establishes a transition period when previous 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.

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period, the previous standard may be used, but justification for using the older version should be provided “when a newer version of the standard raises significant questions that were not previously addressed,” the FDA wrote.

The separate FDA draft guidance, Recognition and Withdrawal of Voluntary Consensus Standards, details how “any interested party” can nominate a standard for recognition by the FDA.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.