FDA Pulls Outdated Draft Guidance Documents


In what it calls a move to improve the efficiency and transparency of the guidance development process, the U.S. Food and Drug Administration (FDA) is withdrawing 47 draft guidance documents that were published before Dec. 31, 2013 and never finalized, the Association for the Advancement of Medical Instrumentation (AAMI) is reporting.

According to an announcement in the May 6 Federal Register, the FDA has received a growing number of requests from the public to clarify specific issues, leading to the publication of draft guidance, some of which was written for industry, some for FDA reviewers, and some for both.

“Many of these draft guidances were not finalized … because of higher priorities and resource issues,” according to the announcement. The agency noted that new information and emerging technologies have made these draft documents outdated.

The withdrawn documents cover a range of device-, drug-, and biologic-related topics, including  guidance on ventilators, a primer on medical device interactions with magnetic resonance imaging systems, and recommended warning for surgeon’s gloves and patient examination gloves.

The oldest document slated for removal was one from 1988 titled Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions.

The FDA has taken steps it says are intended to improve transparency in the guidance development process. In December 2011, the agency issued a report on good guidance practices. It lists the steps in the process, from guidance initiation, to the development of documents in working groups, through finalization.

At an agency workshop in June 2014, FDA officials acknowledged they faced a number of challenges in improving the program, including a lack of staff resources. Several audience members also voiced concern about what they described as the slow speed with which the FDA moves guidance documents from draft to final form. One attendee suggested "term limiting" drafts, suggesting a 24- to 30-month period.  After that point, the draft document should either be withdrawn, or the comment period should be reopened.

Source: AAMI

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