Devine Guidance

Class I Devices in the United States

By Dr. Christopher Joseph Devine
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Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.

Some of the sweetest words medical device manufacturers like to hear are: “Class I Exempt.” Simply put, no pre-market application, a.k.a., 510(k) submission is required to market the device. However, device manufacturers are still required to register their establishment with FDA, pay the $2,575 (FY 2013), and list their device(s) using the FDA Unified Registration and Listing System (FURLS).

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.

Class I Devices
The doctor has taken the liberty of extracting what FDA considers requirements for a Class I device from the agency’s website.

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.
So what does  FDA require for Class I devices from a Quality System regulation (QSR) standpoint? Typically, the term “General Controls” is associated with Class I devices. General controls consist of: 
  • 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.
For the regular readers of Dr. D’s fine prose on quality and regulatory compliance, I am sure you are wondering why the doctor has not thrown in one of his smart-alecky remarks. Here cones one. It is incumbent upon the Chief Jailable Officer (CJO) to ensure all devices, under his or her domain, are appropriately cleared and listed in FURLS. Hey CJO, this is not rocket science, it is the law. The doctor has been led to believe the price of orange jumpsuits has skyrocketed so compliance with QSR appears to be a viable option. Besides, no device manufacturer wants FDA to back-up the proverbial turnip truck and hall away a truck full of adulterated/misbranded devices. 
Takeaways
For this week’s guidance, the doctor will leave the readers with just one takeaway. Although the regulatory burden is greatly reduced for Class I devices, in the eyes of FDA it is still a medical device. Manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.

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. 

References: 

  1. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation.  Washington, D.C.: U. S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. 

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

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