Dive Brief:
- Clarification around the Special and Abbreviated 510(k) and the Breakthrough Devices programs, Least Burdensome Provisions Principles, and regulation of Clinical and Patient Decision Support Software are among the CDRH priorities topping the wishlists of both AdvaMed and the Medical Imaging & Technology Alliance for the next fiscal year. The comment period for the proposed priorities closed this week.
- The industry groups responded to an October 4 CDRH call for feedback on a total of 28 proposed guidance priorities for the next year, which included an A list of 11 guidances to be finalized and 10 guidances to be drafted, and a less pressing B list that includes five to be finalized and two to be drafted. The organizations also proposed certain revisions to older guidances.
- The 28 total proposed guidance priorities for the next year marks an increase over last year's goal of 20 guidances, 16 of which were completed.
Dive Insight:
Industry relies on guidance documents to help it navigate FDA's complex rules, standards for approvals and a myriad of other regulatory actions.
While AdvaMed and MITA affirmed many of CDRH's A list priorities, the trade groups also recommended shifting certain guidances between lists, or adding others that CDRH did not plan to address in the next fiscal year.
AdvaMed encouraged CDRH to place greater importance on several guidances regarding in-vitro diagnostics, particularly as they relate to oncology trials and therapeutic products, like one released Thursday night. As for new draft guidances, AdvaMed said that recommendations relating to FDA inspections, content of premarket submissions for medical device software, and the leveraging of artificial intelligence and machine learning would be most important to the organization's member companies.
MITA concurred with AdvaMed on the importance of bumping unique device identifiers (UDIs) from the B list to the A list, and also encouraged CDRH to add guidance on labeling requirement for medical devices to the A list. MITA disagreed with AdvaMed that Patient Engagement in Clinical Trials was of high importance.
The organizations placed low importance on stated CDRH priorities like guidance for humanitarian device exemptions and labeling best practices for surgical staplers.
During fiscal year 2018, which ended Sept. 30, the device center issued 14 guidances from the A list and two from the B list. Among those finalized documents were Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, as well as Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.
Since FY19 began Oct. 1, FDA has already checked a few guidances off the list including the agency's thinking on CLIA waivers, UDIs, and cybersecurity.