Safe Medical Devices for Children (2006) / Chapter Skim
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5 Monitoring of Postmarket Study Commitments Involving Medical Devices
5 Monitoring of Postmarket Study Commitments Involving Medical Devices
Pages 183-198
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From page 183... ...
recognizes that it has not done well in monitoring the status and fulfillment of studies that it has required in connection with the premarket approval of medical devices or subsequently. To the extent that significant questions related to device safety have been asked and then neglected by the agency, the result may be avoidable harm to patients and their families and a breach of public trust.
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From page 184... ...
Thus, attention to the specification and monitoring of postmarket study commitments becomes more critical. This chapter examines FDA's monitoring of the status and fulfillment of commitments for postmarket studies of medical devices.
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From page 185... ...
Should uncertainty exist about the relationship of surrogate endpoints to clinical benefits or observed clinical benefits to ultimate outcome, the regulations specify that applicants are to continue research to verify clinical benefit, usually by continuing studies that are already under way.3 In addition, applicants may also commit to conduct postmarket studies after a drug has been approved. If a mandatory postmarket study is not completed or does not confirm the expected benefit, FDA may order the drug withdrawn from the market (21 CFR 314.81(d)
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From page 186... ...
The time taken by the agency to review submitted reports for postmarket studies and determine whether they were acceptable varied from a few days to several years. In its report, OIG recommended that FDA should establish accountability for monitoring postmarket study commitments for drugs and develop standards, procedures, or guidelines for doing so.
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From page 187... ...
Also, because information about study findings is not included in the database or made accessible by a link to other information sources, the database does not contribute to the greater availability of public information about the safe and effective use of drugs with children. Proposals for a Registry of Clinical Trials The FDA study commitments database for drugs is not intended to serve as a registry of drug studies for the purposes of making more comprehensive information available about what clinical trials have been initiated and completed and with what aims and results.
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From page 188... ...
The 1997 legislation directed FDA to report on the feasibility of including device clinical trials in the database. That report, which was submitted in November 1999, recommended that no action be taken to include devices until experience with registration of pharmaceutical trials was evaluated (FDA, 1999a)
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From page 189... ...
They thus would exclude many single-arm, so-called pivotal clinical studies that are initiated and relied on to support initial FDA approval of high-risk medical devices or additional indications for their use. They likewise would exclude many of the postmarket studies discussed in this chapter.
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From page 190... ...
107250) , however, requires a report from the agency by 2007 on the effect of medical device user fees on FDA's ability to conduct postmarket surveillance, the extent to which device companies comply with postmarket surveillance requirements (including postmarket study commitments)
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From page 191... ...
Separate information from FDA indicated that the great majority of postmarket studies involve clinical investigations, but a few specify additional bench or animal studies (personal communication, Thomas P Gross, M.D., Director, Division of Postmarket Surveillance, CDRH, November 9, 2004)
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From page 192... ...
In response to the committee's question about postmarket studies involving devices used with children or devices with possible pediatric as well as adult uses, the agency stated that it had not recorded such information in the past. Because the Medical Device User Fee and Modernization Act of 2002 provided that user fees for PMA applications and 510(k)
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From page 193... ...
. The letter also reported that CDRH has, in recent years, required only two Section 522 Postmarket Surveillance studies.6 The progress of the plans for the two current studies is being monitored by an interdisciplinary review team, and "limited experience" indicates "that manufacturers are honoring these commitments" but "[n]
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From page 194... ...
and that an internal audit revealed problems with complaint handling, manufacturing quality systems, documentation procedures, and staff training. With respect to the other device, FDA described concerns about serious adverse events (e.g., aneurysm rupture, device migration)
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From page 195... ...
Furthermore, it has not maintained any system for systematically monitoring the status of these study commitments based on periodic reports or updates from either its own staff or sponsors. The agency was able to identify the two postmarket surveillance studies (required under 21 CFR 822)
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From page 196... ...
Such studies may represent a particularly clear instance of FDA and manufacturer agreement on the importance of follow-up investigations. Recommendation 5.1: Congress should require FDA to establish a sys tem for monitoring and publicly reporting the status of postmarket study commitments involving medical devices.
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From page 197... ...
In addition to directing that FDA make public information about the status of study commitments, Congress should provide for the responsible reporting of study findings. As discussed in Chapter 7, the creation of an independent drug safety board and the developing of responsible procedures for making information from postmarket studies publicly available should provide some guidance on procedures for evaluating the soundness of study findings and the appropriateness of making information public.
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From page 198... ...
Beyond study monitoring, another step the agency should consider to increase accountability for postmarket surveillance is to provide its advisory committees with periodic follow-up information on the products they have reviewed. Such information should cover the status, methods, and findings of required postmarket studies and also include adverse event reports, safety alerts, recalls, or other actions associated with previously reviewed products.
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