CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR864.9125]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 864 -- HEMATOLOGY AND PATHOLOGY DEVICES

Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products

Sec. 864.9125 Vacuum-assisted blood collection system.

(a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.

(b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]