CDRH issued final guidance for industry and agency staff on how to deal with deficiencies the agency identifies when reviewing device marketing applications.
Under MDUFA IV, the FDA committed to updating the guidance to state that all deficiency letters issued by the agency will include a statement of the basis for the deficiencies, as well as the specific scientific or regulatory issue.
The agency also committed to conducting a supervisory review of each deficiency letter to ensure that all cited deficiencies are relevant to the authorization decision.
The guidance describes approaches applicants can use to respond to the identified deficiencies. Updating guidance issued in 2000, the final document outlines the principles that the agency uses for identifying deficiencies, including considering alternative solutions, and requesting the least amount of information necessary.
Separately, CDRH issued final guidance using a Q&A format to clarify the appeals process.
The guidance answers questions about what a “significant decision” is under section 517A of the FD&C Act and what constitutes a “substantive summary” of a decision.
CDRH also clarified that only those firms that have submitted or plan to submit 510(k)s, PMAs, HDEs, IDEs or Breakthrough Designation Requests can request a substantive summary without having to submit a formal request under the Freedom of Information Act.
“Since FDA will only be providing these summaries to the owner of any proprietary information contained therein, generally there should not be any need to withhold trade secret or confidential commercial information (CCI) or any other information in the summary. If someone other than the owner of a device wishes to obtain a substantive summary of a 517A decision regarding such device, that person would need to file a FOIA request,” the agency said.
Read the deficiencies guidance here: www.fdanews.com/10-03-17-Deficiencies.pdf.
Read the 517A Q&A guidance here: www.fdanews.com/10-03-17-QA.pdf. — Ana Mulero