Implementing the Medical Device Amendments: The Case of Serum Vitamin B 12 Kits

21 U.S.C. §321(h)(2) [emphasis supplied].

See, e.g., 44 Fed. Reg. 52950-53963 (1979) (classification of hematology and pathology medical devices).

Beck W.S. in Hematology. Williams W.J. , Eds. (McGraw-Hill, New York) (1972) at 265.

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).

Lau K.S. , 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.

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).

Kolhouse J.F. , 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).

Cooper B.A. Whitehead V.M. , supra note 7, at 818.

Kolhouse J.F. , supra note 7, at 789.

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.

Comptroller General of the United States. Food and Drug Administrations Investigation of Defective Cardiac Pacemakers Recalled by the General Electric Company at 21 (1975).

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.

21 U.S.C. §334.

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”).

United States v. An Article of a Drug … Bacto-Unidisk, 394 U.S. 784, 798 (1969).

Cooper T. , Device Legislation. Food Drug Cosmetic Law Journal 26(4): 165, 171–72 (April 1971).

21 U.S.C. §360(c).

21 U.S.C. §§351(f)(1), (2).

21 U.S.C. §360c(f)(1)(A).

21 U.S.C. §§360c(a)(1), (2).

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.

NCCLS, Summary of FDA Minutes (February 16, 1979).

NCCLS, Summary of Task Force Recommendations (March 16, 1979).

Letter from Bureau of Medical Devices, FDA (March 9, 1979).

It should be noted emphatically that these positions represent the view of the manufacturers and not the advising panel or the FDA.

FDA Drug Bulletin (November 1979).

43 Fed. Reg. 32988-99 (1978) (See §860.7).

Id. at §860.7(e)(1).

The Concepts of Efficacy and Safety, Chap. 2, Assessing the Efficacy and Safety of Medical Technologies (1978).

Id.

Testimony, at FDA Advisory Panel on Hematology (November 19, 1979).

Beck W.S. , supra note 3.

See, e.g., Foote S.B. , supra note 10.

45 Fed. Reg. 7493 (1980).

45 Fed. Reg. 7490–93 (1980).