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Implementing the Medical Device Amendments: The Case of Serum Vitamin B12 Kits
Published online by Cambridge University Press: 01 January 2021
Extract
Within the past decade, in vitro diagnostic kits have become increasingly important to the clinical laboratory. Smaller hospital laboratories, in particular, lack the resources to develop and evaluate the large number of laboratory tests considered standard today. For these laboratories, the commercially available reagents, packaged with directions for use, provide a simple method of adding an otherwise unavailable test to the laboratory “menu.” These laboratories, however, are precisely the ones which lack the time, resources, and personnel to evaluate each kit. Furthermore, many manufacturers provide little or no information to back up their labeling claims for in vitro diagnostic kits, and there is little independently published information on the subject. The laboratory director is left to rely upon the integrity of the manufacturer, and typically chooses between competing products on the basis of unit cost and ease of performance.
Congress addressed these problems with the Medical Device Amendments of 1976, which extended the application of the Food, Drug and Cosmetic Act.
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References
21 U.S.C. §321(h)(2) [emphasis supplied].Google Scholar
See, e.g., 44 Fed. Reg. 52950-53963 (1979) (classification of hematology and pathology medical devices).Google Scholar
Beck, W.S. in Hematology. Williams, W.J., et al., Eds. (McGraw-Hill, New York) (1972) at 265.Google Scholar
Rosenthal, H.L., Sarrett, H.P., The Determination of Vitamin B12 Activity in Human Serum, Journal of Biological Chemistry 199(1): 433–42. (November 1952).Google ScholarPubMed
Lau, K.S., et al., Measurement of Serum Vitamin B12 Level Using Radioisotope Dilution and Coated Charcoal, Blood: The Journal of Hematology 26(2): 202–14 (August 1965). In this test, radioactive vitamin B12 was specifically bound by a protein and was displaced by the non-radioactive B12 present in test sera. The resulting drop in radioactivity, when compared with various control samples, was proportional to the amount of B12 present in the patient's serum. This test depended upon two extremely critical variables: (1) the presence of a specific binder protein for the biologically active form of vitamin B12, and (2) proper maintenance of the conditions of the test solution so that the binding protein was active. Initially, these kits were based upon the original radiodilution assay method, but for various reasons which have never become clear, all the commercially available kits have been modified to substitute a relatively non-specific binder protein (“R” protein) for a portion on the highly specific binder protein, and to change the conditions (pH) so that any biologically active vitamin B12 binder present in the test mixture was inactive.CrossRefGoogle ScholarPubMed
See Raven, J.L., Walker, P.L., Barkhan, P., Comparison of the Radioisotope Dilution — Coated Charcoal Method and a Microbiological Method (L. leichmannii) for Measuring Vitamin B12 in Serum, Journal of Clinical Pathology 19(6): 610–13 (November 1966).CrossRefGoogle Scholar
Kolhouse, J.F., et al., Cobalamin Analogues are Present in Human Plasma and Can Mask Cobalamin Deficiency Because Current Radioisotope Assays Are Not Specific for True Cobalamin, New England Journal of Medicine 299(15): 782–92 (October 12. 1978); Cooper, B.A. Whitehead, V.M., Evidence that Some Patients with Pernicious Anemia Are Not Recognized by Radiodilution Assay for Cobalamin in Serum, New England Journal of Medicine 299(15): 816–18 (October 12, 1978).CrossRefGoogle Scholar
See, e.g., Foote, S.B., Loops and Loopholes: Hazardous Device Regulation Under the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, Ecology Law Quarterly 7(1): 101–36. (1978) at 103, n. 8.Google Scholar
Comptroller General of the United States. Food and Drug Administrations Investigation of Defective Cardiac Pacemakers Recalled by the General Electric Company at 21 (1975).Google Scholar
Food and Drug Administration, Practice and Procedure, 1975: Joint Hearings Before the Subcommittee on Health of the Committee on Labor and Public Welfare and the Subcommittee on Administrative Practice and Procedure of the Committee on the Judiciary, 94th Cong., 1st Sess., 1–273.Google Scholar
21 U.S.C. §334.Google Scholar
See, e.g., AMP Inc. v. Gardner, 389 F.2d 825 (2d Cir. 1968) (upholding FDA designation of a medical device as a “new drug”).Google Scholar
Cooper, T., Device Legislation. Food Drug Cosmetic Law Journal 26(4): 165, 171–72. (April 1971).Google Scholar
21 U.S.C. §360(c).Google Scholar
21 U.S.C. §§351(f)(1), (2).Google Scholar
21 U.S.C. §360c(f)(1)(A).Google Scholar
21 U.S.C. §§360c(a)(1), (2).Google Scholar
The National Committee for Clinical Laboratory Standards (NCCLS) is a nonprofit organization devoted to developing “consensus” standards for the clinical laboratory. Members include representatives from academia, private laboratories, government, and industry. Proposed standards are developed in various subcommittees, reviewed by the appropriate parent committees, circulated for public comment, voted on by the membership, and adopted by the Board of Directors. Currently, there are ten approved standards, with another 66 in various stages of development. Although at present the adoption of these standards by individual manufacturers is entirely voluntary, it is anticipated that the FDA may ultimately adopt many of the standards (perhaps in modified form) under the Medical Device Amendments.Google Scholar
NCCLS, Summary of FDA Minutes (February 16, 1979).Google Scholar
NCCLS, Summary of Task Force Recommendations (March 16, 1979).Google Scholar
Letter from Bureau of Medical Devices, FDA (March 9, 1979).Google Scholar
It should be noted emphatically that these positions represent the view of the manufacturers and not the advising panel or the FDA.Google Scholar
43 Fed. Reg. 32988-99 (1978) (See §860.7).Google Scholar
Id. at §860.7(e)(1).Google Scholar
The Concepts of Efficacy and Safety, Chap. 2, Assessing the Efficacy and Safety of Medical Technologies (1978).Google Scholar
Testimony, at FDA Advisory Panel on Hematology (November 19, 1979).Google Scholar
Beck, W.S., supra note 3.Google Scholar
See, e.g., Foote, S.B., supra note 10.Google Scholar
45 Fed. Reg. 7493 (1980).Google Scholar
45 Fed. Reg. 7490–93 (1980).Google Scholar