Regulatory News

CDRH Finalizes Appeals Process Guidance, Adding New 'Significant Decision' Category

The US Food and Drug Administration (FDA) this week released a final version of a guidance on the Center for Devices and Radiological Health's (CDRH) appeals process.

Background

The 2013 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) instituted a new provision under Section 603 of the act intended to overhaul how FDA's medical device regulatory division, CDRH, handles appeals.

Section 603 amended Section 517A of the Federal Food, Drug and Cosmetic Act (FD&C Act)—the section which regulated device appeals—by calling for CDRH to provide "a substantive summary of the scientific and regulatory rationale for any significant decision" made regarding the non-approval of a product. In addition, Section 603 called for CDRH to allow companies to request a "supervisory review" of any significant decision so long as the request is submitted within 30 days.

That language, while specific in parts, left much to FDA to define, most notably the definition of "significant decision."

With FDASIA on the books, FDA released a final guidance document on the topic in May 2013 outlining the appeals process under 517A. For example, FDA said any appeals should use a step-wise approach (i.e. appeal to the branch chief before appealing to the center director), but that certain appeals may be accelerated ("telescoped") through CDRH if public health needs warrant expediency.

For more on FDA's May 2013 guidance, CDRH Appeals Processes, please click here.

Q&A Guidance

Shortly after the release of the aforementioned guidance, FDA also released an accompanying document, Questions and Answers About 517A, which defined some of the terms introduced in FDASIA Section 603.

As of 30 July 2014, that guidance has been finalized by FDA.

The draft version of that guidance had defined "significant decision" as any of the following actions:

• finding a 510(k) to be not substantially equivalent (NSE)
• finding a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) Application to either be not approvable or approvable
   
  with conditions
• denying approval for an Investigational Device Exemption (IDE) application
• failure to reach an agreement regarding a protocol under Section 520(g)(7)

However, in the final version of the guidance, FDA also adds a fifth category to this list:

• placement of a Clinical hold on a trial under Section 520(g)(8) of the FD&C Act

Other FDA actions, such as the issuance of a PMA "major deficiency" letter, a "refuse to accept" letter, a CLIA waiver decision, a Warning letter or a 510(k) "additional information" request, do not fall under Section 517A, but may be reviewed under 21 CFR 10.75 of the FD&C Act instead, FDA explained in the guidance.

Substantive Summary Definition

In addition, the guidance also defines the term "substantive summary," which FDA said should include:

• an explanation of the rationale for the regulatory decision
• documentation of significant controversies or differences of opinion, i.e., ones the resolution of which had a direct bearing on the regulatory decision
• references to published literature and consensus standards upon which the decision-maker relied

This definition did not change relative to the draft guidance.

FDA also clarifies in the guidance that it will permit companies to access "substantive summaries" without needing to file a Freedom of Information Act (FOIA) request.

Questions and Answers About 517A (FR)