Is Your Product Regulated?

Is My Product Regulated by FDA's Center for Devices and Radiological Health?

The U.S. Food and Drug Administration (FDA) regulates medical devices to assure their safety and effectiveness and develops, and carries out a national program designed to control unnecessary exposures to, and assure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products. The Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic (FD&C) Act.

The FD&C Act contains provisions, that is, regulatory requirements, that define FDA's level of control over these products. To fulfill the provisions of the FD&C Act that apply to medical devices and radiation-emitting products, the FDA develops, publishes and implements regulations. These regulations are initially published in the Federal Register (FR) for public comment. The FR is a compilation of the daily government activities including proposed and final regulations.

Final regulations are subsequently placed or codified into the Code of Federal Regulations (CFR) on an annual basis. Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects of design, clinical evaluation, manufacturing, packaging, labeling and post market surveillance of medical devices. In addition, the regulations address standards and product reports that apply to radiation-emitting products.

One of the most important aspects of getting a medical device or radiation-emitting product to market is to know where to begin. The requirements for marketing a radiation emitting non-medical device differ from those radiation-emitting products that are also medical devices. For example, a non medical laser would require an initial report, whereas a laser for use in ophthalmic surgery would require both an initial report and the filing of a 510(k) premarket notification to obtain clearance prior to marketing.

The starting point is determining whether the product you plan to market is a medical device, as defined in section 201(h), or a radiation-emitting product, as defined in section 531 of the FD&C Act, or both. If your product meets either of these definitions, it will be subject to the provisions of the FD&C Act, that is, there are FDA regulatory requirements that must be met before a product can be marketed in the U.S. The purpose of Device Advice is to help you decide whether your product is subject to FDA regulations, and if so, to identify what these regulatory requirements are and help you comply with them.