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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
A. The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device in commercial distribution prior to May 28, 1976, under section 513(d) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(d)):
1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, and the Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), CDRH.
2. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors of the Office of Blood Research and Review (OBRR), the Office of Vaccines Research and Review (OVRR), and the Office of Cellular, Tissue and Gene Therapies, CBER.
3. The Director and Deputy Director, Center for Drug Evaluation and Research (CDER), and the Director and Deputy Director, Office of New Drugs, CDER.
B. The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device first intended for commercial distribution after May 28, 1976, under section 513 (f)(1)(A) of the Act (21 U.S.C. 360c(f)(1)(A)):
1. The Director and Deputy Director, CDRH, and the Director, Deputy Directors, Division and Deputy Division Directors, Associate Division Directors, Branch Chiefs, and Director, Program Operations Staff, Office of Device Evaluation (ODE), Chief, Premarket Notification Section, ODE, and the Director and Deputy Director, Division and Deputy Division Directors, OIVD, CDRH.
2. The Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OCTGT, CBER.
C. The following officials are authorized to make determinations and issue orders classifying devices under section 513(f)(2)(b) of the act:
1. The Director and Deputy Director, CDRH.
2. The Director and Deputy Directors, ODE, CDRH, and the Director and Deputy Director, OIVD, CDRH.
3. The Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OCTGT, CBER.
D. The Director and Deputy Director, CDRH, and the Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OCTGT, CBER, are authorized to issue Federal Register notices under section 513(f)(2)(C) of the act (21 U.S.C. 360c(f)(2)(C)) announcing classification of devices under section 513(f)(2)(B) of the act (21 U.S.C. 360c(f)(2)(B)).
2. REDELEGATION.
These officials may not further redelegate those authorities.
3. EFFECTIVE DATE.
This delegation was signed by the Commissioner on June 27, 2003.