The guidance clarifies the meaning of “significant decision” within the CDRH’s regulatory lexicon and explains how the regulator handles disagreements over such decisions with agency stakeholders.

The guidance notes that the documentation and review procedures required by Section 517A of the FD&C Act apply only to “significant decisions” (or “517A decisions”) in the premarket review of device submissions. While the term “significant decision” isn’t defined within the Act, the CDRH believes the following types of decisions should be considered as “significant”:

  • 510(k): Not substantially equivalent, substantially equivalent
  • PMA/HDE: Not approvable, approvable with conditions, approval
  • Breakthrough devices: Granting, denial
  • IDE: Disapproval, approval
  • Failure to reach agreement on a protocol under Section 520(g)(7)
  • “Clinical hold” determinations under Section 520(g)(8)

The FD&C Act also requires that a “substantive summary” of the scientific and regulatory rationale used to reach a “significant decision” for the types of submissions listed above be provided by the CDRH upon request.

According to the guidance, the CDRH considers “substantive summary” to be either the final version of the review memorandum by the lead reviewer or another summary document containing:

  • An explanation of the rationale for the regulatory decision;
  • An explanation regarding how the least burdensome requirements were considered and applied consistent with Sections 513(i)(1)(D), 513(a)(3)(D) and 515(c)(5) of the FD&C Act;
  • Documentation of significant controversies or differences of opinion; or
  • References to published literature and consensus standards upon which the decision maker relied.

Finally, the document outlines who is eligible to request documentation of 517A decisions and explains how such requests are processed under the Freedom of Information Act.

The guidance document was developed as a companion to the Appeals Guidance, which outlines the time frames for processing the appeals of significant decisions.