About FDA

Reclassification

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
check mark Total check mark Total
2013 Temporary Mandibular Condyle Reconstruction Plate 872.4770 NEI     Final Order check mark 3   0
Intra-aortic Balloon and Control System 870.3535 DSP Final Order(1) check mark  
External Counter-pulsating Devices 870.5225 DRN Final Order(1) check mark  
2014 Sorbent Hemoperfusion System 876.5870 FLD Final Order(1) check mark 4   1
Stair-climbing Wheelchair 890.3890 IMK Final Order check mark  
Sunlamp Products and UV Lamps Intended For Use In Sunlamp Products 878.4635 LEJ Final Order   check mark
Endosseous Dental Implant (Blade-form) 872.3640 NRQ Final Order check mark  
Implanted Blood Access 876.5540(b)(1) MSD Final Order check mark  
2015 Nonroller-type Blood Pump 870.4360 KFM Final Order(1) check mark 3   0
Shortwave Therapy 890.5290 ILX Final Order check mark  
Electrical Salivary Stimulator System 872.5560 LTF Final Order check mark  
2016 Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair 884.5980 OTP
PAI
Final Order
(call for PMAs)
Final Order
(reclassification)
  5 check mark 1
Redesignation as Extracorporeal Circuit and Accessories For Long-term Respiratory/cardiopulmonary Failure (ECMO)(2) 870.4100 BYS Final Order check mark  

External Pacemaker Pulse Generator (EPPG)

870.3600 DTE Final Order check mark  
And Pacing System Analyzers 870.3605 check mark  
External Cardiac Compressor (ECC) and Cardiopulmonary Resuscitation (CPR) Aids 870.5200 DRM Final Order check mark  
870.5210 check mark  
Iontophoresis 890.5525 EGJ Final Order check mark  
Thoracolumbosacral Pedicle Screw Systems
Semi-Rigid Systems(3) (4)
888.3070 NKB
NQP
Final Order

check mark

check mark

 
2017 Surgical Instrumentation for Use With Urogynecologic Surgical Mesh 884.4910 OTP
OTN
Final Order   0 check mark 2
Influenza Virus Antigen Detection Test Systems Intended for Use Directly with Clinical Specimens 866.3328 GNX
GNT
Final Order   check mark
2018 Sharps Needle Destruction Device(5) 880.6210 MTV Final Order check mark 3   0
Single-Use Internal Condoms(6) 884.5340 MBU Final Order check mark  
Electroconvulsive Therapy Devices 882.5940 GXU Final Order(1) check mark  

(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."

Page Last Updated: 03/22/2019
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