Getting approval to sell medical products in the U.S

Compiled by Juli Case

My company has developed a medical product that we’d like to introduce into the U.S. market. What do we have to do to get it certified?

Products intended for medical use that are made out of textiles are usually classified as medical devices. The governing body for these types of products is the Food & Drug Administration (FDA), often under the auspices of the FDA’s Center for Devices and Radiological Health (CDRH). Products are placed into a class determined by the risk factor. Something that presents a low risk is a Class I, a medium risk is a Class II, and a high risk is a Class III. Requirements for a Class III device will be more stringent than those for a Class I device.

An FDA Good Guidance Practice (also known as a GGP or simply the Guidance document) is the document that explains the process, from the processing, content, and evaluation of regulatory submissions; to the design, production, manufacturing, and testing of regulated products; and, lastly, the inspection and enforcement procedures. Be advised that the process takes time and involves a lot of painstaking detail, which is why many companies chose to use a consultant to help them.

SOURCE FDA, 888 463 6332

SOURCE FDA Center for Devices and Radiological Health +1 240 276 3150, fax 800 638 2041

Juli Case is IFAI’s information and technical services manager.