We previously posted about CDRH’s guidance on the appeals process contained in the Food and Drug Administration Safety and Innovation Act (FDASIA), and its issuance of a draft Q&A discussing section 517A. Section 517A imposed timeframes for appeal decisions that were shorter than those originally proposed by CDRH, and required CDRH to provide a “substantive summary” of the rationale for any “significant decision” being appealed.
On July 30, 2014, CDRH issued the final Q&A, with only two modifications:
- Clinical hold decisions have been added to the list of significant decisions subject to the shorter review timeframes in 517A. Since clinical holds do have a substantial impact on the ability of a company to proceed with its product development, adding this to the list of significant decisions is likely non-controversial and appropriate.
- Examples of non-significant decisions have been provided, including 510(k) requests for additional information, PMA major deficiency letters, refuse to accept letters, 522 orders, CLIA waiver decisions, Warning Letters, and responses to requests under section 513(g).
Otherwise, the draft and final guidance documents are the same. This means that the final Q&A still fails to answer the most critical question: when will the substantive summary be provided to the requester? As we noted in our prior post, under section 517A, the appeal must be filed within 30 days of the significant decision. If the substantive summary is provided beyond the 30 day timeframe, or even late in the timeframe, it will be of little to no use in preparation of the appeal, contrary to the apparent statutory intent. It is disappointing that the final guidance does not clearly state that the summary must be provided promptly so as to facilitate the timely preparation of an appeal that directly responds to FDA’s concerns.