For those readers not familiar with the agency’s classification system, the FDA employs three classifications of devices premised on risk, with Class I being the lowest risk and Class III being the highest risk. Dr. D does not typically employ an “effusive” (look-it-up) style of writing; however, the doctor cannot place enough emphasis on understanding the regulatory pathways associated with placing finished medical devices on the U.S. market. Enjoy.
FDA has exempted almost all class I devices (with the exception of Reserved Device) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with “#” are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.
If a manufacturer’s device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm9
IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
- Registering the medical device manufacturing establishment with the FDA;
- Listing devices with FDA using FURLS;
- Manufacturing devices in accordance with FDA Good Manufacturing Practices (GMP), with a focus on quality control, complaint handling, and record keeping; and
- Labeling medical devices to provide explicit instructions for use (IFU), including warning statements, to ensure the safe and effective use of medical devices in their intended use.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.