Consumer product safety is important regardless of the type of product; any item can be dangerous if it enters the stream of commerce with hazardous defects. But when it comes to products that are going to be implanted directly into or onto the human body, it is blatantly obvious that safety standards need to clear a higher bar; dangerous or defective medical devices can have dramatic health impacts.
For this reason, there are requirements in the law that manufacturers of moderate- to high-risk medical devices that have received U.S. Food and Drug Administration approval provide publically available scientific evidence verifying the safety and effectiveness of these devices. However, according to a new study printed in JAMA Internal Medicine, such information is not available for most moderate- to high-risk medical devices.
Researchers in the study looked at 50 medical devices approved by the FDA over a five year period. Of these, the study results said only eight had publically available data about clinical studies and other information in sufficient detail to be in compliance with the law.
In response to the findings, the FDA said that in clearing medical devices, it reviews far more data than is publically available, and that its approach has served the public well. But, if the information used by the FDA in issuing approvals truly vindicates a medical device as safe, and considering the requirements of the Safe Medical Devices Act of 1990, it is unclear why this data is not being made publically available as a matter of course.
Source: The Wall Street Journal, “Medical Devices Lack Safety Evidence, Study Finds,” Thomas M. Burton, Sept. 29, 2014