Guidance: Following Consensus Standards Can Shave Review Times
Medical device manufacturers using recognized consensus standards as part of FDA submissions have a new guidance to follow on those standards.
Applicants may use FDA-recognized standards in premarket submissions to simplify and streamline the review process, the guidance says. If done properly, conformity to standards will reduce the amount of documentation manufacturers need to submit and may result in a shortened review process.
Although rare, comprehensive consensus standards are particularly useful because they are complete performance standards for specific medical devices. These standards may include acceptance criteria that describe the relevant performance characteristics of a specified device. Therefore, conformity to the standard should minimize the amount of data and documentation needed in a 510(k) submission to demonstrate substantial equivalence.
The FDA maintains the current list of recognized standards at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
The guidance, “Recognition and Use of Consensus Standards; Guidance for Industry and FDA Staff,” can be found at www.fda.gov/cdrh/osel/guidance/321.pdf.