FDA Regulation, Medical Device Classification
Feb 14 2022
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are : Device Regulatory Controls 1. Class I General Controls
With Exemptions
Without Exemptions
2. Class II General Controls and Special Controls
With Exemptions
Without Exemptions
3. Class III General Controls and Premarket Approval The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.
Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product. A discussion of the meaning of intended use is contained in The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.
Class I / II Exemptions Certain Class I and Class II devices are exempt from premarket notification [510(k)] requirements as well as the Medical Device Good Manufacturing Practices (GMPs), also referred to as the Quality System (QS) Regulation. A Class I or Class II device that is exempt from 510(k) requirements must still comply with other requirements (known as regulatory controls) unless the device is explicitly exempt from those requirements as indicated in the regulation for that device type. 510(k) Exemptions Most Class I and some Class II devices are exempt from 510(k) requirements, subject to certain limitations (see sections 510(l) and 510(m) of the Federal Food, Drug & Cosmetic Act). A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device. Devices which may be exempt from 510(k) requirements are :
Preamendments devices; and
Class I and Class II devices specifically exempted by the FDA.
The term “preamendments device” refers to a device legally marketed in the U.S. before the enactment of the Medical Device Amendments on May 28, 1976 and that has not been :
Significantly changed or modified since then; and
For which the FDA has not determined a Premarket Approval (PMA) application is needed to provide reasonable assurance of the device’s safety and effectiveness.
A listing of Class I and Class II devices exempt from 510(k) requirements is available on the Medical Device Exemptions 510(k) and GMP Requirements website. General limitations to the exemptions are found in Title 21 of the Code of Federal Regulations (CFR) in sections 862.9 through 892.9. Additionally, the FDA may partially limit the exemption from 510(k) requirements to specific devices within a classification regulation. It is important to confirm a device’s 510(k) exemption status and any limitations that may apply. Quality System Regulation/Good Manufacturing Practices Exemptions All medical devices are subject to the Quality System Regulation (21 CFR 820), also referred to as the “Current Good Manufacturing Practices” or “Good Manufacturing Practices,” unless there is an exception or exemption noted in 21 CFR 820. Regardless of the Class, you should refer to the device’s specific classification regulation to confirm regulatory requirements.
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SOURCE : https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-ii-exemptions