News Feature | May 11, 2015

FDA Pulls 47 Outdated Draft Guidance Documents

By Jof Enriquez,
Follow me on Twitter @jofenriq


The FDA recently withdrew 47 outdated draft guidance documents that were never finalized after they were initially published, all prior to December 31, 2013. The documents cover many areas, including medical devices, diagnostic products, pharmaceuticals, and biologics.

According to a notice in the Federal Register, the FDA said that its good guidance practices (GGPs) on the creation and issuance of guidance documents have always required eliciting comments and stakeholder input after issuance of a draft guidance. However, the feedback process has become lengthy for these older documents to the extent that their content has become obsolete. 

"In recent years, FDA's guidance workload has increased due to requests from the public for guidance to clarify specific issues and statutorily mandated guidances," the FDA stated in the notice. "Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn."

The FDA revealed in a recent letter to Congress that the agency usually takes, on average, between 425 days and 797 days to finalize a draft guidance, according to an article in Regulatory Affairs Professional Society (RAPS).

Draft guidance documents do not create legally enforceable rights or responsibilities and do not legally bind the public or the FDA, the agency clarified in its notice.

Among the withdrawn guidances pertaining to medical devices and diagnostics are:

  • “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms
  • Assessing the Safety and Effectiveness of Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions
  • Draft Guidance for Preparation of PMA Applications for Testicular Prostheses
  • Emergency Resuscitator Guidance
  • 510(k) Submission Requirements for Peak Flow Meters
  • Reviewer Guidance on Face Masks and Shield for CPR
  • Reviewer Guidance for Ventilators
  • Testing MR Interaction with Aneurysm Clips
  • A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems
  • Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology
  • Class II Special Controls Guidance Document: Tinnitus Masker Devices
  • Class II Special Controls Guidance Document: Absorbable Hemostatic Device
  • Heart Valves: Investigational Device Exemption and Premarket Approval Applications
  • Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief
  • Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals

The FDA notice contains the full list of withdrawn draft guidance documents.