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Safe Medical Devices for Children
The CDRH letter stated that the agency is updating its information technology system and reviewing how it communicates requirements for the studies. It noted that the agency expects to create a searchable database that includes more information about condition-of-approval studies. 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).
Although FDA cannot require studies as a condition for clearing a device under 510(k) procedures, it can encourage voluntary studies as part of discussions with sponsors related to clearance decisions. (Subsequent to clearance, the agency can order a Section 522 Postmarket Surveillance study.) Given that no comprehensive information is available on required postmarket studies, it is not surprising that such information is likewise not available on these kinds of voluntary studies.
As this study was nearing completion, FDA released an internal two-year-old report on the status of conditions-of-approval study commitments (after the New York Times filed a request for it under the Freedom of Information Act) (Meier, 2005). The report, which was essentially completed in 2003, examined the period from January 1, 1998, through December 31, 2000. It found that 45 (35 percent) of the 127 PMAs approved during the period examined included provisions for a postmarket study (Brown et al., 2005). For 26 of these, the report authors could find no mention of the studies in the manufacturer’s annual reports (which are supposed to include such information). After additional data collection, including a survey of the lead reviewers for the approval applications, the authors found information on 16 of the unmentioned studies but could find nothing for 8. For 11 studies for which results were due (or past due), the agency had not received results for 6. The report provided no details about the topics of the required studies.
Subsequently, AdvaMed, a trade association representing device manufacturers, sent a letter to the Director of CDRH that reported the results of a survey of its members about the status of the 45 postmarket study commitments that were mentioned in the CDRH report (Secunda, 2005). The letter stated that 12 of its members were responsible for 22 of those 45 study commitments. These companies reported that 16 of the 22 studies were completed on time (as the time table was understood by the companies), that 2 were completed within a year of the expected date, and that 2 studies were ongoing. One study had been cancelled because the company withdrew the indication for which the study was requested, and the start of another study was being delayed until the product was widely enough distributed to generate a sufficient number of study subjects. The letter did not discuss whether the companies had appropriately reported on the stud-