On March 14, 2017 the US FDA published a notice in the Federal Register (FR Doc Number 217-04938) indicating that the Agency has identified a list of Class II devices that, when finalized, will be exempted from premarket notification requirements (i.e. 510(k)).
The list encompasses 1,003 class II devices, many of which were previously identified in the FDA’s 2015 final guidance entitled, “Intent to Exempt Certain Unclassified, Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.” Each of the Class II devices from this guidance are contained in the proposed list.
Importantly, the Class II devices on the proposed list will only be exempt from the premarket notification requirements and are not exempt from other regulatory controls (e.g. cGMP, labeling, packaging).
This notice was published to comply with the 21st Century Cures Act, signed into law on December 13, 2016. This law requires the FDA to publish a list of each type of Class II device that no longer requires premarket notification under section 510(k) in order to provide a reasonable assurance of safety and effectiveness. The Agency is required to publish this list within 90 days of the date of enactment of the 21st Century Cures Act and every 5 years afterwards. In addition, the Agency must provide at least a 60-day comment period and then, within 210 days of enactment, the Agency must publish the final list of exempt devices. Consequently, the notice also indicates that the FDA is requesting public comments on the announcement. Comments must be received by the Agency no later than May 15, 2017.
To read the announcement in the Federal Register, please follow the link below:
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
To read more on the FDA’s 2015 final guidance, please follow the link below:
Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements