Health IT Topics Among List of Top Guidance Priorities for FDA in 2015
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The agency's A-list included final guidance and draft guidance on: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).
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