Focus on safety, and leave the question of efficacy to post-market studies; this recent recommendation comes from the former commissioner of the FDA, Andrew Von Eschenbach. As imagined, this suggestion has created quite a stir in the industry and many are weighing in with their thoughts.
MassDevice covered the story, pointing out that “cutting efficiency standards from the review process isn't likely to be a popular move among patient advocacy groups, but medical device makers may not find it so alluring either.”
MedCity News also published an article titled, “FDA should prize safety over efficacy. Here’s why it won’t happen.” The article points out that lowering the standards for FDA clearance could make the industry more vulnerable to lawsuits, and that’s something the industry, congress, and advocacy groups just won’t allow.
Safety and protection of human subjects is one of the most important keystones in a clinical research. Adverse effects will occur in almost all investigative products. However, whether these events make the product “unsafe” depend, to some extent, on what the product accomplishes. It seems that safety and efficacy are deeply entwined, and it won’t be so easy to separate the two.
What are your thoughts? Should the FDA redirect its focus to approving devices specially based on safety, then efficacy?