As experience and knowledge about a device increase, the original classification of a device can be changed through reclassification. Two reclassification processes for medical devices described in the Food Drug and Cosmetic Act (FD&C Act) are explained below.
Reclassification Process Described in Section 513(e) of the FD&C Act
Under section 513(e) of the FD&C Act, the FDA may, on its own initiative or in response to a petition from an interested person, reclassify a device type based on “new information.” The new information received about a device must be publicly available “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2).
If the FDA or a petitioner proposes that the device type be reclassified into a lower class (from Class III to Class II, Class II to Class I, or Class III to Class I), the FDA or the petitioner must identify sufficient valid scientific evidence to support a determination by the FDA that the safety and effectiveness of that device type can be assured through the less stringent regulatory controls of the lower class.
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted, changing the reclassification process from rulemaking to an administrative order process. To reclassify a device under section 513(e) of the FD&C Act, the FDA must do the following before making the reclassification final:
- Publish a proposed order in the Federal Register which includes the proposed reclassification and a summary of the valid scientific evidence that supports the reclassification,
- Convene a device classification panel meeting, either before or after the proposed order has published, and
- Consider comments from the relevant public docket.
If the FDA is proposing to reclassify the device from Class II to Class III, the available scientific evidence must show that general controls and special controls together are not sufficient to provide a reasonable assurance of safety and effectiveness of the device. If, on the other hand, the FDA is proposing to reclassify the device from Class III to Class II, the available scientific evidence must show that general controls and special controls are sufficient to provide a reasonable assurance of safety and effectiveness of the device. Finally, if the FDA is proposing to reclassify a device from either Class III or Class II to Class I, the available scientific evidence must show that general controls would provide a reasonable assurance of safety and effectiveness of the device.
Reclassification Process Described in Section 513(f)(3) of the FD&C Act
Devices that were not available on the market before the enactment of the Medical Device Amendments to the FD&C Act, on May 28, 1976 (generally referred to as postamendments devices), are automatically classified into Class III without any FDA rulemaking process, regardless of the risks they pose.
The reclassification of these devices may be initiated by the FDA itself or it may be in response to a petition from a manufacturer or importer. As with the 513(e) reclassification process described above, in order to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. If the FDA receives a petition requesting a reclassification, it may ask a device classification panel to review the information and make a recommendation on the petition. Once all information has been considered, the FDA will issue an order approving or denying the petition. If the FDA approves the petition, the order will describe the reasons for reclassification and identify the risks to health (if any) presented by the device type.
Summary of Medical Devices Reclassified Since 2013
On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(c) of FDASIA requires the FDA to annually post the number and type of devices reclassified in the previous calendar year. The table below lists all devices that the FDA has reclassified beginning with the calendar year 2013, the first full calendar year after the enactment of FDASIA. The FDA intends to update the table after each final reclassification.
The Class III preamendments devices that were reclassified under section 513(e) of the FD&C Act are also listed in a table on the FDA’s 515 Project Status Web page.
|Year||Device||CFR||Product Code||Final Reclassification of Device||Class III to|
Class II or Class I
|Class I or Class II to Class III|
|2013||temporary mandibular condyle reconstruction plate||872.4770||NEI||Final Order||3||0|
|intra-aortic balloon and control system||870.3535||DSP||Final Order(1)|
|external counter-pulsating devices||870.5225||DRN||Final Order(1)|
|2014||sorbent hemoperfusion system||876.5870||FLD||Final Order(1)||1||0|