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Procedures for Class II Device Exemptions from Premarket Notification
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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. |
Updated 6/30/1998
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