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SMG 1410.406

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

DETERMINATION OF CLASSIFICATION OF DEVICES

Effective Date: 02/24/2011

[PDF Version]

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.  Director and Deputy Directors, Center for Devices and Radiological Health (CDRH); Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH; and Director and Deputy Directors, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), CDRH

2.  Director and Deputy Director, Center for Biologics Evaluation and Research (CBER); Director and Deputy Directors, Office of Blood Research and Review (OBRR), CBER; Director and Deputy Director, Office of Vaccines Research and Review (OVRR), CBER; and Director and Deputy Director, Office of Cellular, Tissue and Gene Therapies, CBER

3.  Director and Deputy Directors, Center for Drug Evaluation and Research (CDER); and 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.  Director and Deputy Directors, CDRH; 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 Director and Deputy Directors, Division and Deputy Division Directors, OIVD, CDRH

2.  Director and Deputy Director, CBER; Director and Deputy Directors, OBRR, CBER; Director and Deputy Director, OVRR, CBER; and Director and Deputy Director, 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.  Director and Deputy Directors, CDRH; Director and Deputy Directors, ODE, CDRH; and Director and Deputy Directors, OIVD, CDRH

2.  Director and Deputy Director, CBER; Director and Deputy Directors, OBRR, CBER; Director and Deputy Director, OVRR, CBER; and Director and Deputy Director, OCTGT, CBER

D.  The following officials 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)):

1.  Director and Deputy Directors, CDRH

2.  Director and Deputy Director, CBER; Director and Deputy Directors, OBRR, CBER; Director and Deputy Director, OVRR, CBER; and Director and Deputy Director, OCTGT, CBER

2.  REDELEGATION.

These officials may not further redelegate those authorities.

3.  EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on February 24, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision02/24/2011N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs