The U.S. Food and Drug Administration has published its regulatory agenda for 2015.
The government agency posted to its website the draft and final guidance documents its Center for Devices and Radiological Health (CDRH) intends to publish this year. Through negotiations over the Medical Device User Fee Amendments of 2012, the FDA agreed it would meet a variety of goals, one of which is to "post annually a list of prioritized device guidance documents that the agency intends to publish within 12 months of the date this list is published each fiscal year," according to an announcement.
There is an "A" and "B" list of documents, with those under the "A" list the agency's top priorities. Topics the FDA prioritizes for 2015 include Medical Device Accessories, Medical Device Decision Support Software, UDI Direct Marking and Adaptive Design for Medical Device Clinical Studies.
Medical device interoperability and patient access to information both appear on the agency's "B" list.
"Although resource constraints and new issues that emerge over the course of the year may preclude [the Center for Devices and Radiological Health] from issuing every guidance document on the A-list and B-list and may require that CDRH issue guidance documents not on the lists, the A-list and B-list are intended to provide helpful information about CDRH's current priorities for the upcoming fiscal year," FDA said in an announcement. Announcement