Since 1976, the FDA has been regulating, testing, and approving devices that are put onto the market. These standards and methods have not been changing since 1976 and allow for many manufacturers to get low to high-risk products approved faster and with less research using Section 510(k) of the Premarket Approval Process. This section put into place as a last resort is now being used as the exception allowing devices to come onto the market with unknown lorn term effects. On several occasions, these products have been affecting the patients adversely and sometimes causing thousands of dollars in hospital damages or having serious health implications. Some examples of these that can be looked into are Essure, Johnson and Johnson mesh, and metal-metal joint replacements.

The documentary on Netflix: The Bleeding Edge does a great job going into detail and explaining the process of the FDA premarket approval and the trauma some patients are experiencing due to negative health implications.

Sign this petition to encourage the FDA to change the methods of their Premarket Approval Process and Section 510k.