Shifts in the Regulatory Landscape

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Regulatory approval of medical devices is a significant consideration for any innovator or manufacturer of medical technologies.  The U.S. FDA’s regulatory approval processes, including, for example, 510(k) clearances and PMA approvals, are notoriously stringent.  So stringent is the U.S. regulatory procedure that many medical device companies opt to enter the regulatory process elsewhere before entering the U.S.  Europe, with its CE mark, which is commonly felt to be a simpler and more straightforward regulatory process, is a common choice. reports that, due to several factors, of which regulatory complexity is one of the most significant, only 4% of manufacturers approach the U.S. first for regulatory submission.  Conversely, due to the perceived regulatory simplicity in Europe, a staggering 80% of manufacturers approach the European Union first for regulatory submission.  Because of barriers to entry in the U.S., such as high regulatory uncertainty, high cost of required clinical trials, long time-to-market, and complexity of the FDA’s approval process, many manufacturers never ultimately approach the U.S. for regulatory approval.

According to PR-BG, the FDA is trying to simplify the U.S. regulatory procedure and improve the perception thereof.  As a positive result of the FDA’s efforts, backlogs and decision times have been reduced and approval rates have increased.

While the FDA attempts to make its regulatory process easier to navigate, the Irish Times reports that the EU is now attempting to tighten its medical device regulations.  Proposed changes to the regulation of medical devices in the EU are currently being considered and have just come through the European Parliament.  Such beefed-up regulations could very well increase the difficulty and cost of getting products from bench to the European bedside.  Bill Doherty, Vice President of Cook Medical’s Europe, Middle East and Africa divisions states that Europe is an attractive development center for medical device companies, such as Cook, because in Europe companies can get their products to market about three years sooner than in the U.S. and Japan.  Were the proposed regulations to become law, the European regulatory timeline and costs would likely both increase, thereby giving medical device companies serious cause to consider pulling development and manufacturing out of Europe.  According to Doherty, the proposed laws would ultimately stifle Cook’s and other manufacturers’ innovation plans.

As the EU considers making its regulatory process more stringent and the FDA looks to make its regulatory process more accessible, we may begin to see initial filings occurring with increasing frequency in the U.S. and a corresponding decreasing frequency in Europe.  However, as the U.S. is likely to remain relatively strict in its procedures (despite its efforts to ease the approval procedure), we may ultimately see medical device manufacturers moving to other, potentially more favorable, jurisdictions such as parts of Asia and South America.  Only time will tell.


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