FDA's "Accredited Persons" 510(k) review program
This article was originally published in The Gray Sheet
Executive Summary
Seven additional Class II devices are deemed eligible for the program, which begins Nov. 21. The seven hematology products are multipurpose system for in vitro coagulation studies (calibrators only) (21 CFR 864.5425); fibrinogen determination system (calibrators only) (864.7340); whole blood hemoglobin assays (calibrators only) (864.7500); calibrator for cell indices (864.8150); calibrator for hemoglobin or hemotocrit measurement (864.8165); calibrator for platelet counting (864.8175); and calibrator for red cell and white cell counting (864.8185). In addition, six more third parties have been accredited to participate since the agency initially accredited seven organizations in early October ("The Gray Sheet" Oct. 5, p. 18). The six groups are: Applied Science & Technology Associates; Center for Measurement Standards of Industrial Technology Research Institute; Cheiroon BV; Entela, Inc.; Intertek Testing Services; and N.V. Kenna. A list of the devices which each group is eligible to review appears on FDA's website (www.fda.gov/cdrh/modact/accredit.html)
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