How does the FDA affect you? Here’s why you should be concerned…

Recently, Josh Makower MD, Aabed Meer, an MD-MBA Candidate at Stanford, and Lyn Denend, a Research Associate also at Stanford published results of a survey that sought out to (1) investigate problems with medical device company interactions with the FDA and compare these interactions with those necessary for clearance in Europe, (2) assess perception of FDA versus European regulatory pathways from these companies, and (3) provide a quantitative measure of the time and cost to navigate the current FDA system.

The survey gathered data from 203 companies with 213 unique product submissions.  The participating companies represent approximately 20% of medical device companies in the US.

Several key takeaways resulted from this exploration:

  • A large discrepancy exists between the FDA’s internally reported review process time and that experienced by companies.  Where the FDA reported 3 months from receipt to decision, companies reported 10 months from first filing to clearance and a whopping 31 months from first communication to clearance in the US compared to an industry-reported 7 month duration from first communication to certificate for CE marking.
  • On average, it took 2 years longer (3 to 70 months) to bring a product to US patients compared to European patients.
  • The overall perception of the European Authority on obtaining a CE mark was viewed more favorably than the FDA along measures such as clinical, engineering, and statistical competence as well as being more predictable, reasonable, and transparent.
  • To bring a 510(k) product from concept to clearance in the US, required spending on average $31MM to navigate the FDA clearance process, of which $24MM was spent on FDA-related elements.
  • For PMA products in the US, on average $94MM was spent to obtain clearance with $75MM associated with FDA-related costs.  These numbers exclude reimbursement approval and sales/marketing costs.

The study quantitatively demonstrates the impact that current FDA practice is having on medical device development in the US.  The generally poorer perception of the FDA and the increased time to market compared to European counterparts does not bode well for development of innovative and impactful technologies in the US.  It will be interesting to see how the FDA responds.

To read the full report and view the corresponding presentation in their entirety, click here:


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