MEDICAL DEVICE APPROVAL

Christopher P. Pimentel, Esq,

Vice President, Lexten Inc.

Taking a new medical device through the FDA to reach final approval is usually complex and time consuming. The following chapter is only a basic survey of the regulatory landscape facing medical device companies and will reference additional information worth reading.

For detailed FDA Medical Device approval advice, visit http://www.fda.gov/cdrh/devadvice/. Registration, listing, and labeling forms/instructions available from this website are highlighted below.

The Center for Devices and Radiological Health

If your organization is conducting research to commercialize a product that might be classified as a medical device you will need to register with and report to the Center for Devices and Radiological Health (CDRH). A company will deal with different offices of the CDRH throughout the process. While the CDRH review process can be complex, their decision is fundamentally based on whether the benefits outweigh the risks.

The regulatory process may start with registration and listing, which are free and simple. Registration involves notifying the CDRH that your company is in the medical device business. Listing involves submitting a description and classification of the device your company is developing. However, neither registration nor listing is mandatory until 90 days before the device goes to market and many times a company might register and apply at the same time.

If your device is novel or being approved for a new use, you will likely file a Premarket Approval Application (PMA), which involves a good deal of data, time, and money. In those cases where a company wants to bypass the application process, it may either file for an exemption or, more likely, request that all or part of your device be recognized as substantially equivalent to a previously marketed device. The requirements for applying for substantial equivalence depend on how the CDRH classifies your device. The majority of relevant medical devices fall under the Class II or Class III categories, in which case they would usually file what is referred to as a "five-ten-K" (510(k)) application. Other than exemptions, which are discussed later, the 510(k) will always be the preferred application option because it is faster and much cheaper than a PMA.

Following approval, the CDRH becomes a law enforcement body. For as long as the device is marketed for public use, the CDRH will implement surveillance programs, monitor compliance, and enforce both good manufacturing practices (GMP) and post marketing performance standards.