Medical Device Safety Act:
Our current focus is The Medical Device Safety Act of 2017, a bill currently in Congress, which if passed, will restore a patient's right to litigation if harmed by a Class III medical device. ASHES members will also be working with other advocacy groups to get a bill introduced in Congress which will revise the 510(k) process of medical device approval.
ASHES also raises awareness about the pitfalls of our FDA medical device approval processes and post market surveillance, and to help bring about much needed changes to these practices. Our organization was instrumental in getting three bills introduced in Congress regarding Essure and other medical devices covered by premarket approval, as well as overall Medical Device Safety.