The US Food and Drug Administration (FDA) on Monday finalized a rule for appealing decisions about medical devices regulated by the Center for Devices and Radiological Health (CDRH).
The final rule is intended to fulfil requirements established under the Food and Drug Administration Safety and Innovation Act
(FDASIA) and the 21st Century Cures Act
to clarify procedures and timeframes for appealing “significant decisions” to CDRH supervisors and is set to take effect next month.
In 2012, FDASIA added section 517A to the Federal Food, Drug, and Cosmetic Act
(FD&C Act) which specifies that FDA must provide a “substantive summary of the scientific and regulatory rationale for any significant decision” by CDRH and established timeframes for the submission and handling of such appeals. Under Cures
, section 517A was further amended to include significant decisions pertaining to requests for breakthrough device designations.
The final rule also details which decisions are considered “significant” and subject to appeal, as well as establishes procedures for requesting supervisory review of other decisions not covered under FDASIA or Cures
FDA first proposed
the rule in January 2018 and notes that it received only one comment from medical device industry group AdvaMed and one comment that was not relevant to the rule. In the Federal Register
notice for the final rule the agency details its response to AdvaMed’s comments but declined to revise the rule based on those comments.
“The final rule provides transparency and clarity for internal and external stakeholders on CDRH’s process for supervisory review of decisions and provides requesters new predictability through binding deadlines for FDA action on a request for supervisory review,” FDA says.
FDA clarifies in the final rule that it will use the term “517A decision” rather than the phrase “significant decision” to avoid implying that other decisions by CDRH that fall outside the scope of 517A are not significant.
As such, FDA says the final rule pertains to significant decisions related to the submission or review of a 510(k), premarket approval (PMA) application, humanitarian device exemption (HDE), breakthrough device designation, investigational device exemption (IDE), failure to reach agreement on protocol under section 520(g)(7) of the FD&C Act, and clinical hold determinations under section 520(g)(8) of the FD&C Act.
FDA notes that stakeholders can request a review of decisions outside of 517A, but says that such requests for supervisory review must be submitted no later than 60 days after the date of the decision, except when situations outside the control of the submitter such as a government shutdown or snow emergency prevent an appeal from being filed within 60 days.
FDA also certifies in the final rule that it believes the cost impact of the rule to be negligible as the final rule “does not change the effort needed to prepare a request for supervisory review” and thus companies will mostly incur costs related to the time needed to read and understand the provisions of the rule.
Federal Register Notice