Reference: (FDA Device Determination, 2014)
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and post marketing regulatory controls. A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA's Center for Drug Evaluation and Research (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA's Center for Biologics Evaluation and Research (CBER). FDA's Center for Veterinary Medicine (CVM) regulates products used with animals. If your product is not a medical device but regulated by another Center in the FDA, each component of the FDA has an office to assist with questions about the products they regulate. In cases where it is not clear whether a product is a medical device there are procedures in place to use DICE Staff Directory to assist you in making a determination.
Most Class I devices and a few Class II devices are exempt from the premarket notification [510(k)] requirements subject to the limitations on exemptions. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.
A few Class I devices are additionally exempt from the GMP requirements with the exception of complaint files and general record keeping requirements.
Class I/II Devices Exempt from 510(k) and class I Devices Exempt from GMPs
Devices exempt from 510(k) are:
- preamendment devices not significantly changed or modified; or
- Class I/II devices specifically exempted by regulation.
For purposes of 510(k) decision-making, the term "preamendment device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 and which have not been:
- significantly changed or modified since then; and
- for which a regulation requiring a PMA application has not been published by FDA.
Devices meeting this description are referred to as "grandfathered" and do not require a 510(k).
The Food, Drug and Cosmetic Act under section 513(d)(2)(A) authorizes FDA to exempt certain generic types of Class I devices from the premarket notification [510(k)] requirement. FDA has exempted over 800 generic types of Class I devices and 60 class II devices from the premarket notification requirement. The 510(k) exemption is with certain limitations, which are so noted in ".9" of each chapter (See FDA Device Classification, 2014). It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892 or the PRODUCT CODE CLASSIFICATION DATABASE or subsequent FR announcements on class I exemptions and class II exemptions.
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.