Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.

IMPORTANCE Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is "substantially equivalent" to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence. OBJECTIVE To assess the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available. DESIGN Using FDA databases, we determined the device categories of the first 5 implanted medical devices cleared through the 510(k) process in 2008: cardiovascular, dental, general and plastic surgery, neurological, and orthopedic. We then identified the first 2 implanted medical devices approved in each of the 5 categories for each year from 2008 through 2012. The sample of 50 devices included, for example, total hip implants, vascular embolization devices, and surgical mesh. We also identified the 1105 predicates the manufacturers listed for these devices. MAIN OUTCOMES AND MEASURES For each implanted medical device and its predicates, we determined whether clinical or nonclinical scientific evidence was provided to the FDA to support the claim of substantial equivalence and whether this evidence was publicly available. We also determined if safety or effectiveness data were provided. RESULTS Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness. CONCLUSIONS AND RELEVANCE Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.

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Mortality data during a two-year follow-up were obtained on some 400 elderly poor residents of New Haven, Hartford, and West Haven, Connecticut, in 1972-1974. These subjects were cases and controls in a study of the health effects of residential relocation. Initial data collection included a detailed health history, sociodemographic and background variables, and a variety of behavioral and psychological data. The variables selected for analysis in this report were: religious beliefs, social contacts, feelings of well-being, and affective states. Stepwise logistic regressions were used to determine the role of these psychosocial variables in predicting mortality, while controlling for case/control status, demographic variables, and health status (measured by an index maximally predictive of mortality in this sample). Three psychosocial variables were significant predictors: religiousness, happiness (as rated by the interviewers), and presence of living offspring. The first two reduced the risk of mortality primarily among the elderly who were in poor health, while the third one did not interact with health status.

The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US Food and Drug Administration (FDA) through expedited pathways raises questions about whether physicians and patients can make informed treatment decisions. 1 Kim and Prasad 2 reported that for 18 of the 36 cancer drugs that were approved by the FDA from 2008 to 2012 on the basis of a surrogate endpointtypically, tumor shrinkage or progression-free survivalpostmarket studies did not indicate any overall survival (OS) benefit. To determine other potential benefits of these 18 drugs, we analyzed all peerreviewed findings and FDA review summaries for quality of life (QoL) and calculated the drugs' annual cost to assess their value.