To further promote international harmonization of device regulations, the US Food and Drug Administration (FDA) finalized guidance to aid manufacturers in appropriate use of voluntary consensus standards and issued draft guidance on the recognition and withdrawal process.
The final guidance was slightly modified for further clarifications on the regulatory framework drafted in 2014 guidance. These changes include a new section on appropriate use when devices or standards change after an applicant obtains marketing clearance from either FDA’s Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).
A total of 1,176 consensus standards are currently recognized by FDA, up from
1,200 last July. “Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address,” FDA said
Industry trade associations, including the Medical Device Manufacturers Association (MDMA), the Association for the Advancement of Medical Instrumentation and AdvaMed, raised some questions and expressed concerns with the draft version during the public comment period.
A major concern among commenters was in regard to nixing the policy on accepting manufacturers' promissory notes to indicate future conformance with a consensus standard to support premarket submissions to FDA.
“MDMA is particularly concerned about the reversal of FDA’s policy toward the use of promissory statements that has been proposed in the draft guidance,” said President and CEO Mark Leahey said. “The potential effect of this change on emerging medical device companies – particularly small manufacturers focused on development of a single device – has been described by some of our members as ‘devastating.'"
This section was revised in the final version with new details on the "limited cases" in which promissory statements may be deemed acceptable by agency staff to support a regulatory decision.
Separately, the new 8-page draft
guidance document explains the policies CDRH staff use to make determinations on requests for recognition of a voluntary consensus standard. “The use of recognized consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, facilitate market entry for safe and effective medical products, and promote international harmonization,” the agency said.
FDA intends to reach a final decision on these requests within 60 calendar days. Decisions of either complete or partial recognition of a standard are made based on whether it “may meet or satisfy requirements under any one or more” of 23 categories listed in the draft guidance, including device identifier, clinical issue and postmarket activity, among others.