Monday, July 10th, the US Food and Drug Administration (FDA) finalized a list of 1,003 types of class II medical devices that do not present risks requiring premarket notification review to provide assurance of safety and effectiveness.
The list was created under the 21st Century Cures Act and is apart of FDA’s efforts to decrease regulatory burdens and costs for the device industry. The first draft was published in March.
A complete list of the devices exempted can be viewed at the FDA’s Federal Register notice.
RAPS reports that FDA wanted to clarify that the devices exempt from 510(k)s “are not exempt from other regulatory controls, unless such exemption is explicitly provided by order or regulation”.1
Some examples include:
- Manufactured under current good manufacturing practice requirements
- Suitable for the intended use
- Adequately packaged and properly labeled
- Have current establishment registration and device listing with FDA
FDA also noted that: “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.”1
For a list of partial exemption limitations, see table 1 of the Federal Register Notice.
FDA assigned new product codes for the device types that are now exempt or subject to partial limitations. FDA believes that sponsors should review their registration and listing information to determine if their device should be listed using the old codes versus the new classification product codes. FDA also explained, “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.”1
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