Health IT Topics Among List of Top Guidance Priorities for FDA in 2015
January 12, 2015 in News
Details of Guidance List
FDA divided its guidance priorities for 2015 into three lists:
- The A-list, which includes guidance documents that the agency intends to publish;
- The B-list, which includes guidance documents that the agency intends to publish if resources permit; and
- A list of previously released guidance documents for which the agency is seeking “retrospective review” (FDA guidance list, 1/8).
The agency’s A-list included final guidance and draft guidance on:
- Medical device decision support software; and
- Unique device identifiers.
Meanwhile, the B-list included:
- Medical device interoperability; and
- Patient access to health data (Bresnick, EHR Intelligence, 1/9).
Bradley Merill Thompson, a lawyer with Epstein Becker Green, said interoperability — which the federal government has been pushing for — might have been pushed to the B-list because “FDA expects other agencies will take the lead … and perhaps they are planning to play a more supportive role” (Modern Healthcare, 1/9).
FDA is seeking stakeholder comment on the topics (EHR Intelligence, 1/9).