492
Opinion of the Court
V
Medtronic asserts several specific reasons why, even if § 360k does not pre-empt all common-law claims, it at least pre-empts the Lohrs' claims in this suit. In contrast, the Lohrs argue that their entire complaint should survive a reasonable evaluation of the pre-emptive scope of § 360k(a). First, the Lohrs claim that the Court of Appeals correctly held that their negligent design claims were not pre-empted because the § 510(k) premarket notification process imposes no "requirement" on the design of Medtronic's pacemaker. Second, they suggest that even if the FDA's general rules regulating manufacturing practices and labeling are "requirements" that pre-empt different state requirements, § 360k(a) does not pre-empt state rules that merely duplicate some or all of those federal requirements. Finally, they argue that because the State's general rules imposing common-law duties upon Medtronic do not impose a requirement "with respect to a device," they do not conflict with the FDA's general rules relating to manufacturing and labeling and are therefore not pre-empted.
Design Claim
The Court of Appeals concluded that the Lohrs' defective design claims were not pre-empted because the requirements with which the company had to comply were not sufficiently concrete to constitute a pre-empting federal requirement. Medtronic counters by pointing to the FDA's determination that Model 4011 is "substantially equivalent" to an earlier device as well as the agency's continuing authority to exclude the device from the market if its design is changed. These factors, Medtronic argues, amount to a specific, federally enforceable design requirement that cannot be affected by state-law pressures such as those imposed on manufacturers subject to product liability suits.
The company's defense exaggerates the importance of the § 510(k) process and the FDA letter to the company regard-
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