Medical Devices:

FDA's 510(k) Operations Could Be Improved

PEMD-88-14: Published: Aug 17, 1988. Publicly Released: Sep 19, 1988.

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In response to a congressional request, GAO examined the Food and Drug Administration's (FDA): (1) implementation of the premarket notification provision of the Medical Device Amendments of 1976; and (2) day-to-day operations in making its determinations of substantial equivalence.

GAO found that: (1) although FDA guidance for determining substantial equivalence was generally adequate and consistent with the less restrictive reading of the act, its description of performance assessment contained some ambiguities; (2) differences among the reviewing divisions within the Office of Device Evaluation (ODE) concerning manufacturer information suggested a lack of clear office-wide policy and coordination; (3) documentation of premarket notifications was inadequate to evaluate ODE compliance with formal review policy; (4) because of implementation problems, certain classes of medical devices did not meet requirements appropriate to their classification and FDA relied on premarket notifications to control market access to them; and (5) FDA reliance on products marketed prior to 1976 to determine substantial equivalence could cause problems.

Matters for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: The Safe Medical Device Act of 1990, enacted November 1990, includes provisions that address this issue.

    Matter: Congress may want to consider: (1) clarifying the extent to which FDA should evaluate, within the premarket notification process, the effects of technological changes in medical devices on their safety and effectiveness; and (2) developing alternative approaches to the regulation of devices currently placed in classes II and III that could accomplish the original purposes of the amendments.

  2. Status: Closed - Implemented

    Comments: The Safe Medical Device Act of 1990, enacted November 1990, contains provisions to address this issue.

    Matter: Congress should amend the Federal Food, Drug and Cosmetic Act to make the determination of substantial equivalence relative to a currently marketed device rather than a predicate device. This can be accomplished by amending section 513(f)(1)(A)(ii) of the act (21 U.S.C. 360(c)(f)(1)(A)(ii)) to read as follows: "is substantially equivalent to a currently marketed device within such type regardless of when that currently marketed device was introduced or delivered for introduction into interstate commerce, or..."

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: The Safe Medical Device Act of 1990, enacted November 1990, contains provisions to address this issue.

    Recommendation: The Secretary of Health and Human Services should instruct the Commissioner, FDA, to establish a requirement that written documentation of the review and decisionmaking process be included in each premarket notification file. The extent of documentation should vary depending on the seriousness of the questions raised during the review.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Implemented

    Comments: The Safe Medical Devices Act of 1990, enacted November 1990, contains provisions to address this issue.

    Recommendation: The Secretary of Health and Human Services should instruct the Commissioner, FDA, to develop and implement processes, first for identifying scientific issues that require uniform treatment across the divisions of ODE, then for developing policies, and finally for ensuring that these policies are implemented in the review of premarket notifications.

    Agency Affected: Department of Health and Human Services

 

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