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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Determine if your product meets the Definition of a device. If it does, there are FDA requirements that apply. First, see the definition below.
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 postmarketing regulatory controls. A device is:
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 DSMICA Staff Directory
to assist you in making a determination.
Check the Precedent Correspondence (Previous decisions
on products) for information on a related product that may assist you in determining
the requirements you need to consider for your product.
Updated February 28, 2002
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