The FDA’s Center for Devices and Radiological Health plans to finalize guidance this year on policy for regulatory oversight of laboratory-developed tests and medical device reporting for manufacturers.
MDUFA III requires CDRH to post a list of guidance documents that it expects to complete each year. The 2016 list contains 21 priority documents — 12 final and nine draft — plus 13 second-line “B-list” items consisting of five final guidances and eight draft guidances.
Other topics in the priority queue for final guidance this year are:
CDRH plans to develop draft guidance on 510(k) modifications, 510(k) third party review program, medical device decision support software, use of real-world observational patient data to support decision making for devices and public notification of emerging postmarket device signals.
The “B-list” includes final guidance on the reporting of computational modeling studies in device submissions, blood glucose monitoring test systems for prescription point-of-care use, self-monitoring blood glucose meters for over-the-counter use and radiation biodosimetry devices.
The “B-list” calls for developing draft guidance on dual 510(k) and Clinical Laboratory Improvement Amendments Act waiver by application.
The device center also plans to revisit guidance issued in 1976, 1986, 1996 and 2006 as part of an ongoing retrospective review.