CDRH Withdraws 30 Draft Guidance Documents

May 8, 2015

The U.S. FDA plans to withdraw 30 draft guidance documents affecting medical devices issued between 1988 and 2011, because they are obsolete or no longer considered necessary.

Most of the drafts, part of a larger list of 47 drafts being withdrawn agencywide, were never finalized because of higher agency priorities and lack of resources, a Wednesday Federal Register notice says.

The majority of products addressed by the drafts are covered under current standards or will be addressed by future guidance and other FDA regulatory actions. Manufacturers of products covered in drafts that will not be replaced should check the 510(k) database to see what data the FDA has reviewed for similar products or request a presubmission meeting, the agency says.

A number of the withdrawn draft guidances from CDRH cover Class II special controls for devices. Others include:

  • “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (2004);
  • Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions (1988);
  • A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems (1997); and
  • Heart Valves: Investigational Device Exemption and Premarket Approval Applications (2010).

The agency is accepting comments at docket no. FDA-2015-N-1419. View the Federal Register notice at www.fdanews.com/05-11-15-withdrawal.pdf. — Elizabeth Orr