Mounting Evidence Released over the past few months, three industry studies have provided a cumul

Mounting Evidence

Released over the past few months, three industry studies have provided a cumulative view of how contentious manufacturers’ interactions with the FDA have become compared to their dealings with E.U. Notified Bodies (as readers of this column are aware, Competent Authorities in each member state, equivalent to the FDA, delegate some of their authority for review to Notified Bodies); how emerging markets will become more attractive in terms of supporting medical device innovation in coming years; and how similar product recall rates in the United States and the European Union despite the former market’s stricter review process demonstrate the advantages of the European approach.

In late 2010, Stanford University consulting professor of medicine and medical device industry entrepreneur Josh Makower conducted a survey titled “FDA Impact on U.S. Medical Technology Innovation,” with support from the Washington, D.C.-based industry trade group Medical Device Manufacturers Association. The study examined U.S. medical device manufacturers’ experiences working with both the FDA and E.U. regulatory bodies in terms of issues including predictability, reasonability, transparency and overall experience. More than 1,000 firms were surveyed for the study, but only 204 responded. Significant majorities of respondents reported highly positive experiences with E.U. regulators, while few survey participants rated their FDA experiences similarly.

Duration of clearance and approval processes also was considerably longer in the United States than in Europe, according to survey results. Low- to moderate-risk device 510(k) clearances took an average of 10 months, according to respondents, while firms that asked the FDA about clinical studies for such products reported an average of 31 months to successfully obtain 510(k) clearances. Processes for the same or equivalent devices took only seven months on average in the European Union.

The time lag was even more pronounced for high-risk devices. Premarket approvals (PMA) typically took 54 months, compared to 11 months in Europe. And with such drawn-out regulatory processes come significant costs to manufacturers—specifically, about $31 million per low-to-moderate-risk device and about $94 million per PMA device. Of course, shorter time frames for European approvals also have meant lower costs incurred by these manufacturers bringing products to market in the European Union.