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New Section 513(f)(2) - Evaluation of Automatic Class III Designation

Director
Office of Device Evaluation (HFZ­400)

New Section 513(f)(2) - Evaluation of Automatic Class III Designation

ODE Review Staff

Purpose

The purpose of this memorandum is to provide guidance to CDRH personnel and to manufacturers on the process and procedures to be followed by ODE review staff in implementing new Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). This provision, which is referred to as the Evaluation of Automatic Class III Designation provision (also known as "de novo" or "risk-based" classification), was added by Section 207 of the FDA Modernization Act of 1997 (FDAMA). It is intended to apply to low risk products that have been classified as class III because they were found not substantially equivalent (NSE) to any identifiable predicate device.

Guidance

The attached "New Section 513(f)(2) - Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff" was published on February 19, 1998. It sets forth the process, requests, and review procedures for determining class III status under new section 513(f)(2).

Effective Date: February 19, 1998.

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

Updated 6/30/1998

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