In a news conference, researchers at Northwestern University in Chicago said about 98 percent of respondents said lack of predictability of FDA requirements was a major determinant in whether to invest in a new device.
They complained about unclear regulatory guidelines, inconsistent implementation and turnover of reviewers assessing new devices. Two-thirds of those surveyed felt Europe’s regulatory process was more predictable. Respondents at small companies reported more challenges with FDA process than large ones.
Read the Ledger report on FDA device approval.
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