Medical device companies used to prefer launching in Europe before setting their sights on FDA approval, but the U.S. has replaced the European Union as the priority market for medical device companies, according to the survey.
The survey, based on testimony from 104 company leaders found the following:
- Eighty-nine percent of medical technology companies plan to prioritize FDA authorization before going to the EU market.
- Seventy-nine percent of respondents said the FDA is responding well to advances in medical technology, while 34 percent say Europe is adapting well to digital technology.
- Survey respondents praised FDA’s breakthrough device designation program, with 88 percent saying the guidance is at least somewhat clear and 75 percent expressing the belief that it will lead to earlier patient access.
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