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This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health should permanently reassign staffers from its office of science and technology to device evaluation duties, the House Energy and Commerce oversight subcommittee recommends in a June 1 report. For the last several months, CDRH has been sending OST staffers to the office of device evaluation on temporary details of up to two months. When it announced the program in November 1992 ("The Gray Sheet" Nov. 9, I&W-1), the center said it was "a significant increase in terms of our ability to devote resources to the evaluation process." However, the subcommittee says the program has proven to be "little more than a shell game" which "ultimately, serves no one." "Reviewers from ODE have to spend time teaching OST personnel how to review device applications, and this time is wasted when the OST personnel move back to OST," the House panel explains. "Therefore, some resources should be shifted out of OST and into ODE permanently." Subcommittee staff interviews with ODE personnel revealed that "most of the division managers...said that the arrangement as it currently exists is marginal at best. They do not believe the current arrangements will resolve the backlog or result in a long- term solution." ODE personnel also said that the alternative of "sending whole applications over to OST will not work." The permanent transfer of OST personnel to ODE is one of several changes that FDA should carry out immediately, the subcommittee says. Device evaluation activities could be further supported by better matching of OST research projects with ODE needs and by transferring personnel from the office raining and assistance to ODE, the report adds. "There are a number of areas where OST expertise could better be used to complement the statutory requirements of the center," the House panel asserts. "Activities in OST which do not directly support the scientific basis for determining safety and efficacy of devices should be phased out or transferred." FDA recently initiated a review of OST aimed at better integrating its projects with other center activities ("The Gray Sheet" May 24, In Brief). OST personnel could help facilitate the device approval process by developing: "a risk-benefit methodology; an approach to device reclassification; a compendium of biocompatibility products; and guidance documents for the device industry," according to the report. The device center has said it plans to develop a database of device biomaterials ("The Gray Sheet" March 16, 1992, p. 6), but this project currently is unfunded. While also recommending the transfer of personnel from OTA to ODE, the subcommittee notes that the situation in OTA is "somewhat different" in that "many OTA staff have been transferred to the office of compliance and surveillance, including at least 50% of the staff in the division of small manufacturers assistance." The shift "has eliminated a significant portion of the staff that serves a legislative mandate to communicate and provide assistance to the device manufacturers," so "FDA should be very cautious before further weakening DSMA," according to the report. Other suggestions include reforms in the center's device evaluation quality assurance program, which is run by ODE's program operations staff (POS), and its integrity audit program, which is overseen by the center's division of ethics and program integrity (DEPI). In the next six to 12 months, CDRH should "consider establishing an independent and technically qualified group of individuals to periodically review approval or disapproval decisions and make recommendations for management or reviewer performance improvement," the report says. The device center has said it will reduce POS' quality assurance role ("The Gray Sheet" May 31, p. 11), but has not discussed plans to develop an independent quality assurance group. The subcommittee's concerns stem from interviews with ODE personnel, many of whom view POS "as lacking the technical qualifications to assess the adequacy of any decision about a device," according to the report. In addition, "because it is located within ODE, and has the same incentives that motivate reviewers and their managers, POS lacks the independence from the ordinary ODE chain of command to review objectively the soundness of a reviewer's decision." ODE managers also "blamed part for contributing to the backlog" of applications at the device center. To better address ethics and integrity issues, the device center should "develop an internal capability, reporting directly to the Commissioner, to address allegations of wrongdoing with potentially significant programmatic effects, or allegations of improper management actions," the House panel contends. The center's division of ethics and program integrity "has proven unable to undertake a thorough review" to address such allegations, according to the report. The subcommittee specifically cites DEPI's handling of allegations of wrongdoing in ODE's division of ophthalmic devices in 1992. The subcommittee says it determined that "DEPI investigators...found serious deficiencies in DOD, but... they failed to recognize the significance of their findings and did not follow up to fully develop the findings." Problems found by DEPI included: "management disregard of scientific issues"; ** "failure to use reviewer expertise"; ** "overruling reviewer decisions for non-scientific reasons"; ** "lack of proper documentation to support review decisions"; ** "failure to take action against improper conduct, improper relationships between DOD/ODE staff and industry"; ** "improper distribution of confidential information"; ** and "reviewers holding applications until the 89th day so that managers would be pressured to approve reviewers' decisions without appropriate time for review." The report also recommends that the center address "reviewers' need for continuing education (in-house or otherwise)" and improve the reward system for recognizing reviewer performance. These concerns are among those that have been raised by subcommittee staffer Claudia Beville in public presentations over the past several months ("The Gray Sheet" March 8, p. 6). The development of a "usable management information system in CDRH" also is recommended. The subcommittee voices concern over the device center's " develop and harness the potentially valuable information that could be contained in its management information systems." The efficiency of the premarket approval program could be "greatly enhanced" through such a system, the subcommittee suggests. A revamped management information system also should solve problems with the center's medical device reporting system, the report says. "The MDR system currently cannot serve as an early warning system because the data that enters the system cannot be processed for several months...The agency's chronic problems in the area may make it necessary to have an independent expert contractor develop a practical and useful system."

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