The 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 main 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 device type and not an individual device.
The sections of the FD&C Act that address device reclassification are:
- Section 513(e) - Applies to classified devices, except those devices currently classified into class III under Section 513(f)(1).
- Section 513(f)(3) - Applies to postamendments devices classified automatically into class III under Section 513(f)(1).
Note: A postamendments device is a medical device that was not in commercial distribution prior to May 28, 1976. Postamendments devices are classified automatically into class III under section 513(f)(1) of the FD&C Act, without any 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), the 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.
The FDA may issue a final order reclassifying a device under Section 513(e) following:
- The FDA’s publishing of a proposed order in the Federal Register to reclassify based on valid scientific evidence about the device, including its public health benefit, and the nature and, if known, the incidence of risk from using 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.
- The FDA’s convening of a meeting of a device classification panel.
- The FDA’s considering of 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 postamendments device classified automatically 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. To change the classification of the device type, the device must meet the definition of devices that belong in that class. If the FDA receives a petition requesting a reclassification, the FDA reviews the petition for any deficiencies that prevent the FDA from making a decision on it. If the FDA determines that the petition contains no such deficiencies, the 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. After the information is considered, the FDA will approve or deny the petition. If the 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.
- Overview of Medical Device Classification
- Summary of Medical Devices Reclassified Since 2013
- 515 Program Initiative
- 515 Project Status
- Evaluation of Automatic Class III Designation (De Novo)