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. […]

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impair­ment of human health, or which present a potential and unreasonable risk of illness or […]

The Center for Devices and Radiological Health (CDRH) has implemented a Third-Party Review Program.67 This program provides an option to manufacturers of certain devices of submitting their 510(k) to private parties (Recognized Third Parties) identified by FDA for review, instead of submitting directly to CDRH. By law, FDA must issue a final determina­tion within 30 […]

Manufacturers should attempt to make a comparison of the new device to its predicate as easy as possible for the FDA reviewer. The 510(k) notification should therefore include dis­cussion of the similarities and differences between the device and its predicate device, and should make use of comparative tables whenever possible (Fig. 22.1). Comparisons might consider […]

The FDA does not currently accept supplements to amend the submission of a previ­ously cleared 510(k) device. This means that new 510(k) notifications57 must contain all the needed information. Referencing the earlier submission will not work. The 510(k) must also include supporting data to show that the manufacturer has considered the consequences that the change […]

A 510(k) is required when: 1. Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the FD&C Act), anyone who wants to sell a device in the United States is required to make a 510(k) submission at least 90 days prior […]

The following seven examples illustrate when a 510(k) is not required. 1. If an unfinished device is to be sold to another firm for further processing, including components to be used in the assembling of devices by other firms. However, if components are to be sold directly to an end user as replacement parts, a […]

Neither the FDCA or the 510(k) regulations50 specify who must apply for a 510(k)— anyone may do so. Instead, they specify the requirements and actions that must occur prior to introducing a device to the US market. The individuals required to file a 510(k) can be categorized as follows: [6] [7] 3. Repackers or relabelers […]

Most medical devices sold in the United States today are cleared for commercial distri­bution or marketing by premarket notification (Class II). However, most Class I devices and some Class II devices are exempt43,44 from the premarket notification and/or good man­ufacturing practices regulation. The Federal Food, Drug, and Cosmetic Act requires device manufacturers to submit a […]