In a previous post, I discussed guidance on how the FDA intends to use consensus standards to facilitate review of device submissions. Consensus help device manufacturers simplify their submissions using documented evidence that their devices conform to those standards recognized by the agency.

The FDA maintains a program to provide information on how to use standards, which standards are recognized and which are not, and how to request recognition of a standard. Other program activities, such as the pilot program for accreditation of test labs to perform conformity assessments (see this previous post) and participation in global efforts to set consensus standards with the International Medical Device Regulators Forum (IMDRF) and other standards development organizations, are described. A good example of standards applicable to X-ray imaging devices is provided in the Resources list.

It’s worth a look through the recognized standards list to determine whether any may apply to your device. You may also want to use a Pre-Sub to consult with the agency on your proposed use of standards (see here for more information on the program for Pre-Subs).

Text Copyright © 2019 Katrina Rogers