FDA Updates Guidance on Exempt Class II Devices

On July 11, 2017, the US FDA published a final list of Class II devices exempt from 510(k) Premarket Notification Requirements (82 FR 31976).  In an effort to comply with the 21st Century Cures Act of 2016, the Agency originally issued a notice on March 14, 2017 in the Federal Register proposing to exempt a list of Class II devices from the 510(k) premarket notification requirements, with certain limitation (82 FR 13609).  

The factors that the Agency considered in their initial determination were originally discussed in a notice published in the Federal Register on January 21, 1998 (63 FR 3142).   These factors were later discussed in a guidance document issued by the FDA on February 19, 1998 entitled, “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff”.  After reviewing comments from interested persons regarding its proposal, the Agency finalized and published its list of 1,003 devices that the Agency believes no longer require premarket notification to establish a reasonable assurance of safety and effectiveness although, again, with certain limitations.  The list of devices and the details of the general and specific limitations are discussed in the Federal Register notice (82 FR 31976).

In addition to the publication in the Federal Register, the FDA also posted an announcement of the exemptions on its website with important guidance for Sponsors, Importers and Exporters of Medical Devices and Device Labelers that have submitter device identifier (DI) records to the Global Unique Device Identification Database (GUDID) for device types that are exempt or partially exempt from premarket notification requirements.   More specifically, the Agency offered the following guidance:

  • Sponsors with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitation on exemptions, should contact the 510(k) lead reviewer to discuss if their device fall within the general limitation of the exemption.
  • Sponsors with existing 510(k)’s for devices that are considered exempt following the publication of the final list in the Federal Register are not required to take any action.
  • Sponsors who currently hold 510(k)’s for device types that are partially exempt must make a determination whether their specific devices are exempt of non-exempt.
  • The FDA has assigned new product codes to the device types that are now exempt.   Sponsors therefore should review their registrations and listing information to assess whether they should list their device with the new classification product code.   The announcement offers further guidance for Sponsors on this topic.
  • Importers and exporters of medical devices are instructed to use the same product code under which the device is listed
  • Device Labelers that have submitter device identifier (DI) records to the GUDID for device types that are exempt or partially exempt from premarket notification requirements may need to make changes to their record(s) in the future.

Those individuals who are interested in reviewing the full text of the announcement can find it on the FDA’s website  here.