On May 13, 2014, FDA announced the availability of a draft guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”  When finalized, the guidance will supersede FDA’s September 2007 guidance on the use of consensus standards.  The draft guidance is intended to provide further clarity to industry and FDA staff regarding the appropriate use of consensus standards in medical device premarket submissions.

In the draft guidance, FDA reiterates that device sponsors can use consensus standards to demonstrate certain aspects of safety and effectiveness in a premarket approval application (PMA) or certain aspects of substantial equivalence in a 510(k) submission.  Sponsors may submit a “Declaration of Conformity” to an FDA-recognized consensus standard in which the submitter certifies that its device conforms to all applicable requirements under the standard.  The use of consensus standards can “provide clearer regulatory expectations” and “streamline premarket review.”  FDA notes, however, that submitters do not always appropriately use consensus standards.  For example, submitters may attempt to use consensus standards that FDA does not recognize or which do not apply to the particular type of device.  Such improper use of consensus standards can hinder FDA’s review of the submission.

As FDA explained in the Federal Register notice, the draft guidance proposes two policy changes.  First, a submitter may no longer use a Declaration of Conformity if it deviates from the FDA-recognized consensus standard.  Second, a submitter may no longer use a promissory statement—a statement indicating that the device will conform to the consensus standard prior to marketing—to support a premarket submission.  FDA expects that the device will conform to the consensus standard prior to submission.

The draft guidance also contains additional information on the use of consensus standards that was not contained in the 2007 guidance.  For instance, the draft guidance explains the information that submitters should provide when filling out the Standards Data Report for 510(k)s (FDA Form 3654).  Submitters should, for example, identify the consensus standard by its complete title, state whether it is FDA-recognized, and provide adequate justifications for any deviations from the standard.  In addition, the draft guidance explains that FDA may establish a transition period when the agency recognizes a newer version of a consensus standard.  A transition period allows a submitter to continue development of the device according to the earlier version of the consensus standard.  FDA notes, however, that if a newer version of a consensus standard addresses a known safety issue, FDA may ask the submitter to satisfy the portions of the newer standard that address the safety issue.  After the expiry of the transition period, FDA expects that submitters will be able to meet the requirements of the newer consensus standard.

FDA requests comments on the draft guidance by August 11, 2014.