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Highlights

GAO discussed the Food and Drug Administration's (FDA) efforts to regulate the medical device industry under amendments to the Food, Drug and Cosmetic Act, which require FDA to: (1) protect the public against unsafe or ineffective new devices gaining entry to the market; (2) review devices on the market before passage of amendments; and (3) classify all devices according to risk and regulate them.

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Recommendations

Matter for Congressional Consideration

Matter Status Comments
Congress could give FDA the flexibility to develop Class II performance standards on a case-by-case basis by amending section 513(a)(1)(B) of the act to read: "(B) Class II. Performance Standards.--A device which cannot be classified as a Class I device because the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance. The Secretary shall identify those Class II devices for which it is considered necessary to establish a performance standard to provide reasonable assurance of their safety and effectiveness and shall do so in accordance with section 514."
Closed - Not Implemented
On June 3, 1987, Congressman Waxman introduced H.R. 2595, which contains language implementing this recommendation. No action has been taken on the bill.
Congress could eliminate the provision of the act that permits FDA to approve new Class III devices on the basis of substantial equivalence to already marketed devices and require instead that all new Class III devices be subject to a premarket approval review. To implement this change, section 513(f)(1)(A)(i) of the act could be amended to read: "(A) the device--(i) is within a type of device (I) which was introduced or delivered for introduction into interstate commerce for commercial distribution before such date, and which has been classified in Class I or II, or (II) which was not so introduced or delivered before such date and has been classified in Class I or II." Furthermore, section 515(c)(1) could be amended by substituting the word "shall" for "may."
Closed - Not Implemented
On June 3, 1987, Congressman Waxman introduced H.R. 2595, which would implement this recommendation. No action has been taken on the bill.
Congress could, if it decided that a review of all preenactment devices is not needed, amend the act to read: "(b)(1) In the case of a Class III device which--(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before the date of enactment of this section; or (B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type, the Secretary shall by regulation, promulgated in accordance with this subsection, require that such device have an approval under this section of an application for premarket approval, when in the opinion of the Secretary, such premarket approval is necessary to ensure safety and effectiveness."
Closed - Not Implemented
On June 3, 1987, Congressman Waxman introduced H.R. 2595, which would implement this recommendation. No action has been taken on the bill.

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services 1. The Secretary of Health and Human Services should require the Commissioner, FDA, to expand the device experience network (DEN) system to include available medical device literature and studies.
Closed - Implemented
FDA concurred with this recommendation and stated that it will consider expanding the DEN system by including available medical device literature and studies where appropriate. FDA officials noted that such information is being obtained through the use of reporting systems at the National Library of Medicine.
Department of Health and Human Services 2. The Secretary of Health and Human Services should require the Commissioner, FDA, to encourage more complete and continued reporting of medical device incidents by developing an effective means of providing feedback to reporters on the use made of the information furnished and the results achieved.
Closed - Implemented
To provide reporters with more timely information, FDA is including data in acknowledgement letters to medical device reporters explaining the type of action FDA intends to take and how soon the reporter can expect resolution of the problem. FDA is also encouraging reporters to call a toll-free number to obtain information on the status of actions taken on their particular reports.
Department of Health and Human Services 3. The Secretary of Health and Human Services should require the Commissioner, FDA, to develop and promulgate a mandatory experience reporting requirement for manufacturers. The requirements should seek only new information which is essential to FDA needs, can be effectively used, and will not be unduly burdensome for manufacturers to provide.
Closed - Implemented
FDA promulgated regulations, effective December 13, 1984, requiring manufacturers and importers to report medical device malfunctions, deaths, and major injuries.
Department of Health and Human Services 4. The Secretary of Health and Human Services should require the Commissioner, FDA, to develop capabilities to permit greater use of information contained in DEN in order to identify trends and potential problems and to devise appropriate resolutions to those problems.
Closed - Implemented
FDA distributed a users manual to facilitate the use of the DEN system. It provides an introduction to the DEN data system and demonstrates, by example, how to perform several types of computer searches that can be used as reference models. Also, FDA recently awarded a contract for a statistical analysis program that will identify trends and potential problems with medical devices.
Department of Health and Human Services 5. The Secretary of Health and Human Services should require the Commissioner, FDA, to: (1) identify new Class II devices that pose health risks significant enough to require examination of safety and effectiveness data as part of an adequate finding of substantial equivalency; and (2) develop guidelines for determining and documenting the safety and effectiveness of such devices.
Closed - Not Implemented
HHS disagreed with the recommendation for FDA to identify risky Class II devices and develop guidelines for documenting their safety and effectiveness. HHS believes that institution of this proposal would significantly alter the classification and marketing procedures for Class II devices.
Department of Health and Human Services 6. The Secretary of Health and Human Services should instruct the Commissioner, FDA, to: (1) collect information on the scope and nature of device problems caused by user error and inadequate maintenance through an expanded device experience reporting network; (2) analyze the data to identify special problems, concentrations, and trends; and (3) disseminate the results internally and to the private sector to aid in developing solutions.
Closed - Implemented
FDA is developing a report that will highlight major items of interest in the DEN system to inform reporters of important problems they need to be aware of and possibly prevent. FDA plans to disseminate the report to the appropriate audience. Also, FDA awarded a contract for a statistical analysis program that will flag sudden increases in adverse reports for a particular medical device.

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