JOHNSON, Judge:
In this case of first impression, we are asked to determine whether the Medical Device Amendments of 1976 (MDA), 21 U.S.C. §§ 360c et seq., 360k, to the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U.S.C. §§ 513 et seq., 521(a),
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