The company's defense exaggerates the importance of the §510(k) process and the FDA letter to the company regarding the [product’s] substantial equivalence to a grandfathered device. As the court below noted, “[t]he 510(k) process is focused on equivalence, not safety.” As a result, substantial equivalence determinations provide little protection to the public. These determinations simply compare a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.” The design of the [product], as with the design of pre-1976 and other “substantially equivalent” devices, has never been formally reviewed under the MDA for safety or efficacy.Lohr, 518 U.S. at 492-93 (various citations and quotation marks omitted).
Premarket approval, in contrast, imposes “requirements” under the MDA as we interpreted it in Lohr. . . . [I]t is in no sense an exemption from federal safety review-it is federal safety review. Thus, the attributes that Lohr found lacking in § 510(k) review are present here. While §510(k) is “focused on equivalence, not safety,” id., at 493, premarket approval is focused on safety, not equivalence. While devices that enter the market through §510(k) have “never been formally reviewed under the MDA for safety or efficacy,” ibid., the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness. And while the FDA does not “require” that a device allowed to enter the market as a substantial equivalent “take any particular form for any particular reason,” ibid., at 493, the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.Riegel, 552 U.S. at 323 (also removing citations and quote marks).
- The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence. IOM Report Conclusion 7-1.
- The thresholds [for device approval] should be stringent enough to satisfy the agency’s objective of ensuring that marketed medical devices will be safe and effective throughout their life cycles. Id. at 158.
- [T]he current 510(k) process . . . [should] be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle. Id. Recommendation 7-1
- It is essential that the new regulatory framework be based on sound science. . . . The FDA should carefully consider what types of evidence are necessary to demonstrate a reasonable assurance of safety and effectiveness in the new framework. Id. at 158-59.
- The FDA should . . . be clear that its role in facilitating innovation in medical devices is to develop regulatory thresholds that are rigorous enough to satisfy the agency’s primary objective of ensuring that marketed medical devices will be safe and effective throughout their life cycles. Id. at 159.
- The [new approval] process should be based on sound science[,] . . . apply relevant and appropriate regulatory authorities and standards throughout the life cycle to ensure safety and effectiveness[, and] should be risk-based. Id.
- The Food and Drug Administration should investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of Class II devices. Id. at Recommendation 7-4.