FDA Changing Medical Device Review Process

Nov 29, 2018
  • The Food and Drug Administration (FDA) released a statement on Monday that they will be changing their process for medical device approval. According to an article posted by the Associated Press (AP), the reform of the process comes on the heels of a published investigative report from over 50 different news outlets and led by the International Consortium of Investigative Journalists which discovered massive amounts of reported injuries (1.7 million) and deaths (80,000) over the last decade to the FDA in regards to various medical devices.

    Who is leading the overhaul of the current process?

    FDA Commissioner Scott Gottlieb will be overseeing the changes. In the statement he commented on how “We [the FDA] believe that it’s time to fundamentally modernize an approach that was first adopted in 1976.

    What are some issues with the current review process?

    Currently, the FDA approves over 95 percent of medical devices for consumer use. This is in part that many medical devices only have to prove similarities to other devices currently on the market – unlike medications which undergo a different review process. Only those devices that are innovative and definitively “new” have to undergo clinical trials to judge their safety and usability. A few of types of these devices that have been cleared due to comparison are: artificial joints, spinal devices, drug pumps, and imaging scanners.

    Has this call for change been brought up before?

    It has. In fact in 2011 David Chancellor who is considered to be an expert in the FDA review process, brought a panel in front of the FDA to advise the administration about making changes to its process, however at the time the administration disagreed with the panel.

    What if I have been injured by a medical device? What are my options?

    If you or a loved one have been injured by a medical device, contact our office at (303)-999-9999 or (303)-835-9342 to speak with one of our highly experienced attorneys and schedule a free consultation. Please also visit our website at boesenlaw.com for additional information.