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Regulatory Affairs Medtech
US transparency proposals may hurt device firms, industry warns
23 July 2010
Vibha Sharma

The medtech industry has expressed concern over draft proposals from the US Food and Drug Administration to disclose to public information on medical devices and drugs that have not yet been approved1.

Disclosing information on pending device applications – ie pre-market approval applications and pre-market notifications or 510(k)s – are a special concern for medtech companies because patents provide less protection for devices and diagnostics than they do for drugs or biologics, claims industry association AdvaMed...

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