490
Opinion of Stevens, J.
from pre-emption that the FDA has granted, none even remotely resemble common-law claims.11
An examination of the basic purpose of the legislation as well as its history entirely supports our rejection of Medtronic's extreme position. The MDA was enacted "to provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. Medtronic asserts that the Act was also intended, however, to "protect innovations in device technology from being 'stifled by unnecessary restrictions,' " Brief for Petitioner in No. 95-754, p. 3 (citing H. R. Rep. No. 94-853, at 12), and that this interest extended to the pre-emption of common-law claims. While the Act certainly reflects some of these concerns,12 the legislative history indicates that any fears regarding regulatory burdens were related more to the risk of additional federal and state regulation rather than the danger of pre-existing duties under common law. See, e. g., 122 Cong. Rec. 5850 (1976) (statement of Rep. Collins) (opposing further "redundant and burdensome Federal requirements"); id., at 5855 (discussing efforts taken in MDA to protect small businesses from the additional requirements of the Act). Indeed, nowhere in the materials relating to the Act's history have we discovered a reference to a fear that product liability actions would hamper the development of medical devices. To the extent that Congress was concerned about protecting the industry, that intent was manifested primarily through fewer substantive requirements under the Act, not the pre-emption provision; furthermore, any such concern was far outweighed by con-11 All 22 exemptions at 21 CFR §§ 808.53-808.101 (1995) are exemptions for state statutes and regulations regarding the sale of hearing aids.
12 Special statutory exemptions, for example, permit the FDA (with various oversight provisions) to allow investigative, experimental devices to be used in commerce without either PMA review or "substantial equivalence." See 21 U. S. C. § 360j(g); 21 CFR pt. 813 (1995). Moreover, the very existence of the pre-emption statute demonstrates some concern that competing state requirements may unduly interfere with the market for medical devices.
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