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SMG 1410.604

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - RADIATION CONTROL

NOTIFICATION OF DEFECTS IN, AND REPAIR OR REPLACEMENT OF, ELECTRONIC PRODUCTS

Effective Date: 01/05/2010

[PDF Version]

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors, Office of Communication, Education, and Radiation Programs (OCER), CDRH, are authorized to perform all functions of the Commissioner of Food and Drugs (Commissioner), relating to notification of defects in, noncompliance of, and repair or replacement of or refund for, electronic products under section 534 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360kk) and under Title 21, Code of Federal Regulations (CFR), Part 1000, sections 1003.11, 1003.22, 1003.31, 1004.2, 1004.3, 1004.4, and 1004.6; and Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to perform all such functions relating to:

1. Assemblers of diagnostic x-ray systems, as defined in 21 CFR, Part 1000, section 1020.30(b).

2. Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product, as defined in 21 CFR, Part 1000, Section 1040.20(b).

B. The Director and Deputy Directors, OCER, CDRH, and the Director, Division of Mammography Quality and Radiation Programs, OCER, CDRH, are authorized to notify manufacturers of defects in, and noncompliance of, electronic products under section 535(e) of the act (21 U.S.C. 360ll(e)) and under 21 CFR, Part 1000, section 1003.11(a); and the chiefs of District Compliance Branches are authorized to perform all such functions relating to:

1. Assemblers of diagnostic x-ray systems, as defined in 21 CFR, Part 1000, section 1020.30(b).

2. Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp products, as defined in 21 CFR, Part 1000, Section 1040.20(b).

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on January 5, 2010.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial01/05/2010N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs