Two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first, according to a comprehensive industrywide survey about US FDA’s 510(k) product review process by researchers at Northwestern University. According to the poll, which surveyed more than 350 professionals engaged in medical device development in the United States, only 8% of respondents believe US FDA’s 510(k) product review process is the most predictable regulatory system, as compared with roughly two-thirds who favoured the CE marking process.
Seeking regulatory clearance and market launch outside the United States is becoming increasingly common, notes the press release.
• Only 4% of respondents reported approaching US FDA as the first regulator to discuss and plan their submission for a new device, while 80% initially approached EU regulatory bodies.
• In the device-specific portion of the survey, respondents said that 65% of devices were CE marked before receiving US FDA clearance.
• Data suggest that current US review time is more than twice as long as in the EU (part of it attributable to differences in regulatory requirements).
It should also be noted, however, that recent articles in the Financial Times, the Guardian and some professional journals have raised doubts about Europe’s regulatory system and suggested that it might put patients in peril. Regardless of the accuracy of these reports, public perception is key: if demand swells for increased regulatory scrutiny, the European environment may become less hospitable to medtech manufacturers.Norbert Sparrow