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Reclassification Letters

• Medical Device Classification
• Reclassification
• List of Reclassification Letters

Medical Device Classification

The Food and Drug Administration (FDA) has established classifications for each of the generic types of devices and grouped them into medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls
   • With Exemptions
   • Without Exemptions
2. Class II General Controls and Special Controls
   • With Exemptions
   • Without Exemptions
3. Class III General Controls and Premarket Approval

The class to which a device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market.

Devices should be classified in the class with the lowest level of control that will provide a reasonable assurance of the safety and effectiveness of the device. An advisory panel recommendation is required for the initial classification of a device. The agency publishes a proposed rule to classify in the Federal Register which includes the scientific justification to support the proposed classification, serves as notice and affords a period for comment.  Subsequently a final rule is published in the Federal Register to affect the classification.

Reclassification

As experience and knowledge about a device increase, the original classification can be adjusted via the process of  reclassification. Changes in classification are based on FDA's receipt of new information about a device. FDA may, on its own, or in response to an outside petition, change a device's classification by regulation.  A manufacturer who wishes to have a device reclassified to a lower class must convince FDA that the less stringent class requirements will be sufficient to provide reasonable assurance of safety and effectiveness.

FDA notifies petitioners of determinations made on petitions for reclassification by a reclassification letter.  If a determination is made to reclassify a device, FDA publishes a proposed rule to reclassify in the Federal Register which includes the scientific justification for reclassification and which affords a period for comment. Subsequently a final rule is published in the Federal Register which changes the reclassification.

Reclassification Letters

[Accessibility]

Decision Date	Name of Device	Company Name
07/03/2002	Home Uterine Activity Monitor, Corometrics Model 770 Home Uterine Activity Monitoring System	GE Marquette Medical Systems. Inc.
12/28/2001	Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices	BioMerieux Vitex, Inc.
09/04/2001	Absorbable Polydioxanone Surgical Suture	Ethicon, Inc.
10/14/1999	Polymethylmethacrylate (PMMA) Bone Cement	Orthopedic Surgical Manufacturers Association