New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

| Printer friendly version

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed at strengthening the FDA medical device review process and increasing accountability for dangerous products.”

If passed, the Act will require doctors to report medical device-related deaths and serious injuries to the FDA. Under current rules, only medical device manufacturers, importers, and certain user facilities are required to report medical device-related deaths and serious injuries to the FDA.  User facilities are currently defined as “a hospital, an ambulatory surgical facility, a nursing home, and outpatient treatment facility, or an outpatient diagnostic facility which is not a physician’s office.” The proposed Act will extend the existing reporting requirements to include “a physician or physician’s office.”

The Act is the most recent effort by Rep. Fitzpatrick to reform the FDA medical device review and approval process. Reps. Fitzpatrick and Slaughter have pointed to recent controversies related to implantable sterilization devices and power morcellators used in laparoscopic surgery as motivation for introducing the Act. Last year, Reps. Fitzpatrick and Slaughter were part of a group of twelve members of Congress who requested the U.S. Government Accountability Office to investigate the events leading to the FDA’s black box warning against the use of power morcellators in November 2014. Black box warnings are the strongest warnings by the FDA and call attention to serious or life threatening risks.

 

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.