Today’s Federal Register announces a list of 1,003 class II device types that the FDA believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. In an effort to decrease regulatory burdens on the medical device industry and reduce private costs and expenditures required to comply with federal regulation, the FDA is exempting or partially exempting (exempting with limitations) these devices from the premarket notification [510(k)] requirements. The list of exempted device types is final upon publication. This announcement follows streamlined procedures established by the 21st Century Cures Act.
On March 14, 2017, the FDA posted in the Federal Register a list of class II device types that it proposed to exempt. While the public comment period closed after 60 days on May 15, 2017, interested persons may submit additional comments to Bryce Bennett (Gregory.Bennett@fda.hhs.gov) at any time.
The FDA periodically exempts from premarket notification review such medical device types when appropriate. On April 13, 2017, the Agency posted a list of 71 class I device types that the FDA exempted or partially exempted from premarket notification [510(k)].
Medical device types that are exempt from 510(k) are not exempt from other regulatory controls, unless such exemption is explicitly provided by order or regulation. All medical devices must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled, and have current establishment registration and device listing with the FDA.
Additional Information for Sponsors of 510(k)s for Device Types that are Now Exempt or Exempt with Limitations:
- Sponsors with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should contact the 510(k) lead reviewer to discuss if their device falls within the general limitations of exemption per 21 CFR XXX.9 (i.e., the device is exempt and the sponsor may choose to withdraw their submission or receive a “device is exempt” decision letter) or exceeds the limitations (i.e., review of the 510(k) should continue).
- Sponsors with existing 510(k)s for device types that are now considered exempt are not required to take any action at this time.
- Sponsors who currently hold 510(k)s for device types that are partially exempt from premarket requirements must make a determination whether their specific devices are exempt or non-exempt. Partial exemption limitations can be found in table 1 of the Federal Register Notice.
- The FDA has assigned new product codes to the device types that are now exempt, subject to the partial limitations, in order to separate these devices from those that do not fall within the partial exemption limitation under the existing product code. Today’s Federal Register Notice lists the new (exempt) procodes.
- Sponsors should review their registration and listing information to assess if they should list their devices using the original classification product code, which requires premarket notification, or if they should use the new classification product code that is now 510(k) exempt.
- If a sponsor chooses to list its device using a new procode, it should deactivate the existing listing and, create a new one, including the proprietary or brand names under which it is marketed.
- If a sponsor is marketing multiple devices that include products under both the original product code and the new product code, they should leave their existing listings under the old product code active, as appropriate, and create a new listing under the new product code.
- Importers and exporters of medical devices should use the same product code under which the device is listed.
- Device labelers that have submitted device identifiers DI records to the Global Unique Device Identification Database (GUDID) for devices types that are now exempt or partially exempt from premarket notification requirements should be aware that changes may need to be made to these record(s) in the future.
- The FDA is working on updates to the GUDID to make it easier to make changes to device identifier records. We will notify affected labelers when the database updates have been completed and provide further information and instructions.
For additional information, contact DICE@fda.hhs.gov.
Food and Drug Administration
Center for Devices and Radiological Health
Center for Devices and Radiological Health