Medical Devices: FDA's 510(k) Operations Could Be Improved
PEMD-88-14
Published: Aug 17, 1988. Publicly Released: Sep 19, 1988.
Skip to Highlights
Highlights
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.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| 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. | The Safe Medical Device Act of 1990, enacted November 1990, includes provisions that address this issue. | |
| 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..." | The Safe Medical Device Act of 1990, enacted November 1990, contains provisions to address this issue. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | 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. |
The Safe Medical Device Act of 1990, enacted November 1990, contains provisions to address this issue.
|
| Department of Health and Human Services | 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. |
The Safe Medical Devices Act of 1990, enacted November 1990, contains provisions to address this issue.
|
Full Report
Topics
Consumer protectionFood and drug lawMedical equipmentProduct evaluationProduct safetyRecordsSafety standardsPerformance measuresSpecificationsData collection