- Developed a novel medical device?
- Developed a medical device similar to or better than the ones existing in the market?
- Modified or changed the intended use of the device?
- Expanded the indications for use of a device?
- Reprocessed a medical device?
In all the above scenarios, you need to ascertain whether your medical device is exempt, i.e., an FDA review (510(k)) is not required and if the device does meet the exemption criteria. Let us walk you through this information:
What type of devices are exempted?
All devices are classified in accordance with the 16 device Classification Panels. Some devices under each of the Classification Panel are exempt, whereas some require a 510(k) notification. FDA has exempted most of the Class I Devices (except reserved devices) and a few Class II Devices. The exempt list also includes devices exempted by the final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996, and the devices exempted per the FDA Guidance issued on August 14, 2015. The infographic below will direct you to a list of all exempted Class I and II Devices.
How to determine if a device is exempted?
A determination of exemption is made based on the following criteria:
“Risk posed to Patients/Users”
Class I and II Devices that are exempted are low risk devices. Class III devices that are interventional devices come under high-risk category, hence are not exempted.
Technological characteristics have a lot to do with the exemption. E.g., a dental chair without an operating unit is exempt, whereas the one with an operating unit is not exempt (21 CFR Part 872. 6250).
“Indications for use”
The clinical application and target population also play an important role in the exemption. E.g., Water Circulating Hot or Cold Pack is 510k exempt, but the same device is not exempted when used for Infants (21 CFR Part 890.5710).
The provision of exemption has been put in place to relieve the Manufacturer from Premarket Notification Application and enable the FDA to channelize resources to assess devices of significant importance to public health or devices that can pose a huge amount of risk to target patients or users.
Are there other requirements you need to comply with, and what are these requirements?
The Manufacturers need to comply with certain requirements for marketing exempted devices:
(a) Registration and listing: The Manufacturer needs to register their establishment with the FDA and list the generic category, product code, classification name and applicable regulation for the device.
(b) GMP: The manufacturer needs to comply with 21 CFR Part 820 i.e., Quality System (QS) Regulation/ Medical Device Good Manufacturing Practices. The manufacturing sites are subject to inspection by the FDA. Some Class I Devices are also exempted from Quality System/GMP requirements (e.g., 21 CFR Part 886.1605).
(c) Labeling: The manufacturer has to comply with the FDA labeling regulations.
(d) Recordkeeping and complaint files: The manufacturer needs to maintain the relevant records and complaint files after launching the device in the market.