FDA Aims to Speed Device Evaluations with
More Interactive Reviews
In what it calls an effort to improve medical device review efficiency, the U.S. Food and Drug Administration (FDA) is seeking stakeholder feedback on draft guidance covering communication during the submission evaluation process.
The draft, published in the March 5 Federal Register, updates the FDA’s approach to interactive review, which the agency says it wants to use more frequently to speed device evaluations. The draft reflects changes the FDA made as a result of the Medical Device User Fee Act of 2007 (MDUFA II) and the Medical Device User Fee Amendments of 2012 (MDUFA III). Those pieces of legislation authorized the FDA to collect user fees, and, in return, the agency promised greater transparency and faster reviews.
In discussions with device representatives during the development of MDUFA III, the FDA promised even greater transparency, including what it called “new communication commitments.” One of these commitments appears to be increased use of informal interactive reviews to exchange scientific and regulatory information. This type of information exchange is designed to prevent unnecessary delays and reduce the time it takes to get a product to market, according to the FDA.
Previously, the FDA thought interactive reviews would only be appropriate in addressing submission deficiencies deemed minor, something it noted in a February 2008 guidance document. Minor deficiencies included clarification of clinical data; clarification of sterilization validation procedures; and labeling revisions. However, the agency now proposes that the process be expanded to deficiencies that are more significant than “minor,” but can be addressed before the MDUFA performance goal for that submission type. Such deficiencies include requests for limited additional short-term laboratory bench or biocompatibility testing; justification for omitting a test; and additional analysis of clinical data unrelated to a safety or effectiveness endpoint.
In the draft, the FDA says it prefers to conduct interactive reviews via e-mail or fax, as these methods create a permanent record. Phone calls should be used only for clarifications the FDA reviewer can easily document. Although face-to-face interviews and video conferences are important tools, they also involve a lot of coordination and may not be the most effective way to resolve issues while a submission is under review, according to the agency.
The other types of communication the FDA discusses in the draft guidance are acceptance review communications, substantive interactions, and missed MDUFA decision communications.
An acceptance review communication is issued to an applicant within 15 calendar days of the FDA receiving the submission and acknowledges that the agency has received the submission and whether it will accept it. A substantive interaction takes place after the agency has reviewed a submission and needs to follow up with the applicant to resolve any deficiencies. The FDA may place the submission on hold. The communication occurs within 60 calendar days of the receipt of a 510(k) and 90 days of original PMAs and 180-day PMA supplements.
What the FDA calls “Missed MDUFA decision communications” are designed to address outstanding issues that are preventing the agency from reaching a decision on an application, as well as propose meeting dates to discuss these problems.
Interested parties have until June 3 to submit comments here.
Posted: March 5, 2013