FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: Class I, Class II, or Class III. The regulatory class of a device type, as defined in Section 513(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(a)) and its implementing regulation at 21 CFR 860.3, may be changed through the process of reclassification. The primary purpose of reclassification is to apply the appropriate level of regulatory controls for a device type based on the most current information regarding its safety and effectiveness. Reclassification is applied to a particular device type and not an individual device.
The sections of the FD&C Act that address device reclassification are:
- Section 513(e) - Classified devices, except those devices currently classified into Class III under Section 513(f)(1).
- Section 513(f)(3) - Postamendments devices currently classified into Class III under Section 513(f)(1).
Note: Section 513(f)(1) of the FD&C Act is the initial classification method for postamendments devices classified into Class III. A postamendments device is a medical device type that was not in commercial distribution prior to May 28, 1976, with no substantially equivalent preamendments device (medical devices that were in commercial distribution before May 28, 1976) predicate and that has not been previously classified or reclassified. All such device types are automatically classified under Section 513(f)(1) into Class III without any FDA rulemaking process. These devices remain in Class III and require premarket approval (PMA), unless and until the device is classified through the de novo process under 513(f)(2) of the FD&C Act, reclassified into Class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval (PMA).
Section 513(e) of the FD&C Act – This is the Applicable Section of the FD&C Act for Reclassification of Classified Devices, Except Devices Currently Classified Into Class III Under Section 513(f)(1)
For already-classified devices, except those currently classified into Class III under Section 513(f)(1), FDA may initiate, or respond to an interested person's petition for, reclassification of a device type. In either case, the basis for reclassification is the availability of new information regarding the device.
FDA may issue a final order reclassifying a device under Section 513(e) following:
- FDA publishing a proposed order in the Federal Register, which includes the proposed reclassification and a substantive summary of the valid scientific evidence to support the reclassification including the public health benefit of the use of the device, and the nature and, if know, incidence of the risk of the device as well as:
- For reclassification from Class II to Class III: a discussion of why general and special controls are not sufficient to provide a reasonable assurance of safety and effectiveness.
- For reclassification from Class III to Class II: a discussion of why general and special controls are sufficient to provide a reasonable assurance of safety and effectiveness.
- FDA convening a meeting of a device classification panel.
- FDA considering comments received during the set period of time for submitting comments to the public docket for the proposed order.
Reclassification of Devices Under Section 513(f)(3) that are Currently Classified Into Class III Under Section 513(f)(1)
Under Section 513(f)(3), for a postamendment device classified into Class III under Section 513(f)(1), FDA may initiate a reclassification or respond to a petition from an interested person who requests reclassification of a device type to either Class I or II. In addition to the 513(e) reclassification activities described above, in order to change the classification of the device type, the device must meet the definition of devices that belong in that class. If FDA receives a petition requesting a reclassification, FDA reviews the petition for any deficiencies that prevent the FDA from making a decision on it. If FDA determines that the petition contains no such deficiencies, FDA may, for good cause, refer the petition to an appropriate device classification panel to review the information and make a recommendation on the petition. Once the information has been considered, FDA will approve or deny the petition. If FDA approves the petition, an order will be issued describing the reasons for approving the petition and identify the risks to health, if any, presented by the device to which the order applies.