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Small device firms file in EU first

Two-thirds of small medical device and diagnostic companies are seeking marketing clearance for new products in Europe before the US, according to an industry survey about the FDA's 510(k) product review process

Two-thirds of small medical device and diagnostic companies are seeking marketing clearance for new products in Europe before the US, according to an industry survey about the FDA's 510(k) product review process. The survey was conducted by researchers at Northwestern University and funded by the Institute for Health Technology Studies (InHealth), a non-profit foundation that supports research and analysis into the role of medical technology.

The online survey of more than 350 professionals who work in medical device development found that only 8 per cent of respondents think the FDA's 510(k) product review process is the most predictable regulatory system, compared with about two-thirds who said Europe's CE marking process is the most predictable. Ninety-eight per cent of respondents said the predictability of regulatory requirements is a crucial factor in deciding whether to invest in developing a new product.

Seventy-six per cent of respondents found preparation requirements for a 510(k) submission to be uncertain or unclear; 72 per cent said that information requests from FDA reviewers went beyond the requirements established in guidance documents; and 59 per cent reported that no guidance documents existed for their devices.

Uncertainties surrounding the regulatory process may be of greater consequence to small companies than to large ones,  More than two-thirds of all the survey respondents reported that FDA requests had a significant impact on the financial resources of their small businesses.

As a result, many small companies are focusing their early efforts on Europe.  Eighty per cent of survey respondents said their companies approached EU regulatory bodies as the first regulator to discuss and plan their submission for a new device, while less than 10 per cent approached the FDA first.

The survey found that 65 per cent of devices made by companies represented in the research were CE-marked before receiving FDA clearance.

26th May 2011

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