PMA requirements apply to Class III devices. Device product classifications can be found by searching the Product Classification Database.68 The database search provides the name of the device, classification, and a link to the Code of Federal Regulations (CFR), if any. The CFR provides the device type name, identification of the device, and classification information.
A regulation number for Class III devices marketed prior to the 1976 Medical Device Amendments is provided in the CFR. The CFR for these Class III devices that require a PMA states that the device is Class III and will provide an effective date of the requirement for PMA. If the regulation in the CFR states that “No effective date has been established of the requirement for premarket approval,” a Class III 510(k) should be submitted.
Please note that PMA devices often involve new concepts, and many are not of a type marketed prior to the Medical Device Amendments. Therefore, they do not have a classification regulation in the CFR. In this case, the product classification database will only cite the device type name and product code.
If it is unclear whether the unclassified device requires a PMA, use the three-letter product code to search the PMA database and the Premarket Notification 510(k) database. These databases can be found by clicking on the hypertext links at the top of the product classification database web page. Enter only the three-letter product code in the product code box. If there are 510(k)s cleared by FDA and the new device is substantially equivalent to any of these cleared devices, then the applicant should submit a 510(k).
Further, a new type of device may not be found in the product classification database. If the device is a high – risk device (supports or sustains human life, is of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury), and has been found to be not substantially equivalent (NSE) to a Class I, II, or III [Class III requiring 510(k)] device, then the device must have an approved PMA before marketing in the United States. Some devices that are found to be not substantially equivalent to a cleared Class I, II, or III (not requiring PMA) device, may be eligible for the de novo process as a Class I or Class II device. For additional information on the de novo process, see “New Section 513(f) (2)—Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff.”69