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, FDA may initiate, or respond to an interested person's petition for, reclassification of a device type that is already classified. Whether the reclassification is based on FDA's own initiative or in response to a petition from an interested person, the basis for reclassification is the availability of new information regarding the device.
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted, changing the reclassification process under section 513(e) of the FD&C Act 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, and
- Consider comments from the relevant public docket.
If the FDA proposes 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 proposes 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 proposes 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 under section 513(f)(1), without any FDA rulemaking process and regardless of the risks they pose.
Under section 513(f)(3) of the FD&C Act, 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, 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. After all information is 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.
Reclassification Process Described in Section 513(f)(2) of the FD&C Act
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a "not substantially equivalent" (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of FDASIA, on July 9, 2012, to allow a sponsor to submit a De Novo classification request to the FDA without first being required to submit a 510(k).
Summary of Medical Devices Reclassified Since 2013
On July 9, 2012, Congress enacted 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 CDRH 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 II or 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)||4||1|
|Stair-climbing Wheelchair||890.3890||IMK||Final Order|
|Sunlamp Products and UV Lamps Intended For Use In Sunlamp Products||878.4635||LEJ||Final Order|
|Endosseous Dental Implant (Blade-form)||872.3640||NRQ||Final Order|
|Implanted Blood Access||876.5540(b)(1)||MSD||Final Order|
|2015||Nonroller-type Blood Pump||870.4360||KFM||Final Order(1)||3||0|
|Shortwave Therapy||890.5290||ILX||Final Order|
|Electrical Salivary Stimulator System||872.5560||LTF||Final Order|
|2016||Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair||884.5980||OTP
(call for PMAs)
|Redesignation as Extracorporeal Circuit and Accessories For Long-term Respiratory/cardiopulmonary Failure (ECMO)(2)||870.4100||BYS||Final Order|
|External Pacemaker Pulse Generator (EPPG)||870.3600||DTE||Final Order|
|And Pacing System Analyzers||870.3605|
|External Cardiac Compressor (ECC) and Cardiopulmonary Resuscitation (CPR) Aids||870.5200||DRM||Final Order|
|Thoracolumbosacral Pedicle Screw Systems
Semi-Rigid Systems(3) (4)
|2017||Surgical Instrumentation for Use With Urogynecologic Surgical Mesh||884.4910||OTP
|Influenza Virus Antigen Detection Test Systems Intended for Use Directly with Clinical Specimens||866.3328||GNX
|2018||Sharps Needle Destruction Device(5)||880.6210||MTV||Final Order||3||0|
|Single-Use Internal Condoms(6)||884.5340||MBU||Final Order|
|Electroconvulsive Therapy Devices||882.5940||GXC||Final Order(1)|
|2019||Cranial Electrotherapy Stimulator (CES)(7)||882.5800||JXK||Final amendment; Final Order||1||0|
|2020||Reclassification of Medical Image Analyzers||892.2070||MYN||Final amendment; Final Order||1||0|
|2021||Surgical Stapler for Internal Use||878.4740||GAG||Final amendment; Final Order||2||
Final amendment; Final Order
|Hepatitis C Virus Antibody Tests (8)||866.3169||MZO||Final amendment; Final Order|
|Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests (9)||866.3170||MZP
|Final amendment; Final Order|
(1)This device is classified in two different classes based on the device's indications for use or technology.
(2)This was previously referred to as "membrane lung for long-term pulmonary support" in 21 CFR 868.5610 and has been redesignated as noted.
(3)This was previously referred to as "dynamic stabilization systems."
(4)Federal Register Notice with correction of the compliance date for submitting 510(k) amendments.
(5)This was previously referred to as "needle destruction device."
(6)Previously referred to as "female condom" under 21 CFR 884.5330; the regulation 21 CFR 884.5330 remains class III and has been renamed "multiple-use female condom," to distinguish it from the reclassified regulation for "single-use internal condom."
(7)FDA notes that the "ACTION" caption for this final order is styled as "Final amendment; final order," rather than "Final order." Beginning in December 2019, this editorial change was made to indicate that the document "amends" the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.
(8)This was previously referred to as “Hepatitis C Virus Antibody Assay Devices.”
(9)This was previously referred to as “Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices.”