The FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, re-label, and/or import medical devices sold in the United States.

General steps to marketing clearance

1. Make absolutely sure that the product that you wish to market is a medical device, or meets the definition of a medical device according to the FD&C Act. For example, your product may be a medical device and is also an electronic radiation-emitting product with additional requirements.

2. Determine how the FDA may classify your device: Class I, Class II, or Class III. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most importantly, the classification of the device will identify, unless exempt, the marketing process (either Premarket notification [510(k)] or Premarket approval (PMA)) the manufacturer must complete in order to obtain the FDA clearance/approval for marketing.

3. Develop/compile data and/or information necessary to submit a marketing application, and to obtain the FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's Investigational Device Exemption (IDE) regulation, in addition to marketing clearance.

Medical Specialty Categories

The FDA has classified and described over 1,700 different medical device types, which they have organized and categorized into 16 different medical specialties. These specialties are:

Anesthesiology
Cardiovascular
Clinical Chemistry and Clinical Toxicology
Dental
Ear, Nose, and Throat
Gastroenterology and Urology
General and Plastic Surgery
General Hospital and Personal Use
Hematology and Pathology
Immunology and Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Physical Medicine
Radiology