SOURCE: FDA, 2010a.
510(k) submissions containing clinical data) that studies submitted in support often failed to meet fundamental scientific standards. In response, the FDA initiated recruitment of additional scientists, including physicians and scientists, to perform premarket review of devices. While the review standard for 510(k) submissions was unchanged (that is, substantial equivalence), the review determinations began to shift from a descriptive to a data-driven base. The second change was issuance of FDA’s final guidance, in January 1997, advising industry as to when modifications to a cleared device could be made without submitting a new 510(k) notification (FDA, 1997).1 This guidance gave manufacturers autonomy in making decisions about devices with changes that were sufficiently minor as to preclude the need for premarket review. Finally, passage of the FDA Modernization Act in 1997 resulted in exemption of most Class I and many Class II devices from premarket review.2 This Act resulted in decreased numbers of low-risk and, in some cases, moderate-risk devices subject to premarket review.
Those changes in administration, regulation, and statue might have had an effect on the volume of 510(k) submissions. The committee was unable to draw conclusions, however, on the basis of the available data as to whether innovation was influenced in any way by these changes.
1Updated guidance was issued by the FDA on July 27, 2011, after the committee had completed its work.
2Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997).