CFR

207.7—Establishment registration and product listing for human blood and blood products and for medical devices.

(a) Owners and operators of human blood and blood product establishments shall register and list their products with the Center for Biologics Evaluation and Research (HFM-375), 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, on Form FDA-2830 (Blood Establishment Registration and Product Listing), in accordance with part 607 of this chapter. Such owners and operators who also manufacture or process other drug products at the same establishment shall, in addition, register and list all such other drug products with the Drug Listing Branch in accordance with this part.

(b) [Reserved]

(c) Owners and operators of establishments engaged in manufacture or processing of medical devices shall register and list their products with the Center for Devices and Radiological Health, FDA, on Form FDA-2891 (Initial Registration of Device Establishments), FDA-2891a (Registration of Device Establishment), and FDA-2892 (Medical Device Listing), in accordance with part 807.

(d) Owners and operators of establishments engaged in the manufacture or processing at the same establishment of both drug products and medical devices shall (1) register with the Records Repository Team (HFD-143), Center for Drug Evaluation and Research, FDA, and list their drug products in accordance with this part, and (2) register with the Center for Devices and Radiological Health and list their medical devices in accordance with part 807.

Code of Federal Regulations

[45 FR 38043, June 6, 1980, as amended at 50 FR 8995, Mar. 6, 1985; 55 FR 11576, Mar. 29, 1990; 66 FR 59156, Nov. 27, 2001; 69 FR 48775, Aug. 11, 2004]

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