CDRH Outlines Hopes for Interactive Review Process

An industry complaint about the MDUFMA review goals followed from 2002 to 2007 was that the scheme did not give reviewers enough time or flexibility to interact informally with applicants.The new scheme allows FDA to interact informally with applicants to resolve outstanding issues in a timely manner, Tillman said. For 510(k)s, it can pertain to any outstanding issues. For PMAs, it pertains to issues that can be resolved without substantive review or analysis. Examples include administrative items, device drawings that need more detail, labeling revisions, clarification of clinical data or test methods and results, and post-approval study plans."Say you have a software issue," she said. "We will alert you to this error so you can get started working on it. That will help you prepare and submit a response in a timely manner."The timeframe for a response will be agreed upon when FDA contacts the applicant about the issue(s), she said. It is very important that industry provide complete responses to all deficiencies communicated during the review within negotiated timeframes, "even if you don't agree with the question," she noted. Otherwise, the application risks being placed on hold. Industry also must not use the program to request status updates; those just cause delays, she explained.-- Erik Swain