Two studies found that the U.S. Food and Drug Administration (FDA) approval process and post-evaluation for medical devices are both lacking information. This is despite a policy requiring companies to back their claims with scientific data and make the information available to the public.
The analysis found that the U.S. authorities approved 400 medical devices without testing them. The federal agency approval process does not require testing on new medical devices if the product has an existing counterpart in the market.
Study author Diana Zuckerman worked with her colleagues from the National Center for Health Research in reviewing the evidence submitted by the companies and whether this information was released to the public. The team identified 50 new medical devices including hip implants, vascular embolization devices and surgical mesh and 1,105 devices that are already in the market that were used as the basis for approval.
"For implants cleared between 2008 and 2012, however, we repeatedly found that scientific evidence of the substantial equivalence, safety or effectiveness of medical devices was not publicly available in accordance with the legal requirements. To protect the public health and allow for independent judgment of the quality of the scientific evidence that supports the marketing of medical devices, the FDA should enforce the law," the authors wrote.
The first study was published in the Sept. 29 issue of JAMA Internal Medicine.
Another study conducted by researchers from the Pew Charitable Trusts revealed that the FDA also failed to publish the results of the post-market evaluation of the new medical devices that coincidentally don't have published scientific data prior to market release. Post-market evaluation is crucial as it shows the efficacy and safety of these medical devices.
The team found that between 2005 and 2011, the federal agency asked for 223 studies of 158 medical devices. But despite the companies' noncompliance, the FDA did not issue any warning letter or penalty for the delay.
"Given our findings - in particular, that only 1 of 223 studies has resulted in any action other than a labeling change - we encourage the agency to work together with all stakeholders to evaluate how these studies can more effectively be used to improve the public health," the authors wrote.
