Source: http://www.annalsofhealthlaw.com/annalsofhealthlaw/vol_22_issue_1?pg=19
Timestamp: 2019-04-21 22:07:24+00:00

Document:
56. 21 C.F.R § 1271.47 (2012).
57. 21 C.F.R § 1271.50 (2012).
58. Id. This includes “[r]ecords or other information received from any source pertaining to risk factors for relevant communicable disease (e.g. social behavior, clinical signs and symptoms of relevant communicable disease, and treatments related to medical conditions suggestive of risk for relevant communicable disease).” For repeat donors, a bank may perform an abbreviated screening if it has been six months or less since he completed a full screening. An abbreviated screening requires only review and documentation of “any changes in the donor’s medical history since the previous donation that would make the donor ineligible, including relevant social behavior.” 21 C.F.R § 1271.75(e) (2012).
59. See 21 C.F.R. § 1271.75(a)( 1) (stating “if you are the establishment that performs donor screening, you must screen a donor of cells or tissue by reviewing the donor’s relevant medical records for . . . [r]isk factors for, and clinical evidence of, relevant communicable disease agents and diseasesFalse” (emphasis added)); see 21 C.F.R. § 1271.3(s) (“Relevant medical records means a collection of documents that includes a current donor medical history interviewFalse” (emphasis added)).
60. 21 C.F.R. § 1271.75; Guidance for Industry: Eligible Determination for Doctors of Human Cells, Tissues, and Cellular and Tissue-Based Products, U.S. FOOD & DRUG ADMIN. (Apr. 19, 2012), http://www.fda.gov/BiologicsBloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/Tissue/ ucm073964.htm#DONORSCREENING1271.75.
61. 21 C.F.R. § 1271.3(n) (“Donor medical history interview means a documented dialog about the donor’s medical history and relevant social behavior, including activities, behaviors, and descriptions considered to increase the donor’s relevant communicable disease risk.”).
62. See 21 C.F.R. § 1271.3 (How does FDA define important terms in this part?); 21 C.F.R. § 1271.75 (How do I screen a donor?).

References: § 1271
 § 1271
 § 1271
 § 1271
 § 1271
 § 1271
 § 1271
 § 1271
 § 1271