New Regulations May Increase Defective Medical Device Injury Risk
August 11th, 2015|
Regulations set by the U.S. Food and Drug Administration (FDA) are supposed to ensure the safety of all drugs and medical devices in the United States. But the defective medical device lawyers at Ferrer, Poirot & Wansbrough point out that a proposed law may do more harm than good.
According to Health News Review, the 21st Century Cures Act was passed last month by the House of Representatives and consists of new regulations that would overhaul the FDA’s pre-market approval process for medications and medical devices. The act would allow companies to submit sources other than clinical trials as evidence of a product safety. This would allow simple case histories to replace hard data and facts as proof that a medical device functions properly.
The new rules would also require all companies marketing “breakthrough technologies” to have products approved for use even faster than current laws allow. Considering the number of recalls on defective medical products approved based on minimal safety evidence, this change could present an increased safety risk to the public.
The 21st Century Cures Act would also allow companies to be able to hire third parties to conduct safety testing on products, which may present serious conflicts of interest.
Promoting the protection of the public’s health and safety is a top priority of the legal staff at Ferrer, Poirot & Wansbourgh. That’s why we’re hopeful lawmakers will carefully consider the impact of the 21st Century Cures Act will have on the lives of Americans.