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U.S. Department of Health and Human Services

Medical Devices

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Procedures for Class II Device Exemptions from Premarket Notification #K98-2 (FDAMA)

Director
Office of Device Evaluation (HFZ­400)

Procedures for Class II Device Exemptions from Premarket Notification

ODE Review Staff

Purpose

The purpose of this guidance is to establish standard operating procedures for the CDRH to carry out Section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) as amended by Section 206 of the FDA Modernization Act of 1979 (FDAMA). This FDAMA amendment provides that interested persons may petition FDA to exempt class II device types, as defined in 21 CFR 860.3(i), from the premarket notification requirements of section 510(k) of the Act.
 

Guidance
 

The attached "Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff" was published on February 19, 1998. It sets forth the relevant factors and considerations and standard operating procedures for exemption of class II devices from premarket notification.
 

Effective Date: February 19, 1998.

 

Susan Alpert, Ph.D., M.D.

 


PDF version of the Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff is also available.
Information on Documents in Portable Document Format (pdf) is available