21 C.F.R. § 864.9245 Automated blood cell separator.
Title 21 - Food and Drugs
(a) Identification. An automated blood cell separator is a device that automatically removes whole blood from a donor, separates the blood into components (red blood cells, white blood cells, plasma, and platelets), retains one or more of the components, and returns the remainder of the blood to the donor. The components obtained are transfused or used to prepare blood products for administration. These devices operate on either a centrifugal separation principle or a filtration principle. The separation bowls of centrifugal blood cell separators may be reusable or disposable. (b) Classification of device operating by filtration separation principle. Class II (special controls). The special controls for the device are that the manufacturer must file an annual report with FDA for 3 consecutive years. Each annual report must include the following: (1) A summary of adverse donor reactions reported by the users to the manufacturer that do not meet the threshold for medical device reporting under part 803 of this chapter; (2) Any change to the device, including but not limited to: (i) New indications for use of the device; (ii) Labeling changes, including operation manual changes; (iii) Computer software changes, hardware changes, and disposable item changes, e.g., collection bags, tubing, filters; (3) Equipment failures, including software, hardware, and disposable item failures, e.g., collection bags, tubing, filters. (c) Classification of device operating by centrifugal separation principle. Class III (premarket approval). (d) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (c) of this section. See §864.3. [45 FR 60645, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987; 68 FR 9532, Feb. 28, 2003]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9245 Automated blood cell separator.
