We have written in prior issues about the fast-track process employed by the FDA relating to new drug approvals. We have said consistently that the process was being badly abused. It’s now being reported that the vast majority of medical devices recalled over a five-year period were either approved through the fast-track process, or were exempt from any FDA regulation, according to a study published in the Archives of Internal Medicine. According to the study, of the 113 medical devices recalled from 2005 through 2009 due to the risk of serious health problems or death, 80 were cleared through the 510(k) approval process. That is the fast track approach usually reserved for lower-risk medical products. Eight were exempt from FDA approval. Only 21 of the 113 devices had been approved through the full premarket approval process, the study found.
The report from the study stated that the findings “suggest that reform of the regulatory process is needed to ensure the safety of medical devices.” Most of the recalled devices – about 35% – were cardiovascular devices, according to the study. Two-thirds of the recalled cardiovascular devices were cleared by the fast-track process. The FDA’s 510(k) process has come under increased fire after critical medical journal reports, testimony before Congress and statements by public health advocates. These critiques led the FDA to announce earlier this year that it would implement changes to its process of reviewing devices deemed low risk before they go to market. The changes are designed to address some of the 55 recommendations made by two internal working groups set up by the agency. The groups found that the process for 510(k) review was unpredictable, inconsistent and opaque. There should be little doubt that the fast track process has been abused and should be changed by Congress if the FDA is unable to make the necessary changes on its own.
Source: Lawyers USA Online
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