The average cost to bring a low-to-moderate 510(k) product to the market is $31 million, and more than 77 percent of that is spent on FDA-dependent or related activities, according to the report. The orthopedic, spine and cardiovascular devices suffer the most, according to the research.
Nearly half of the respondents in the report said they experienced some reviewer-related delays during the regulatory process, and devices were found to take an average of two years longer to reach patients in the U.S. than in other countries.
Read the Stanford University report on FDA 510(k) clearance costs (pdf).
Read other coverage on the FDA:
– FDA Warns Against Bisphosphonates for Osteoporosis Medication
– FDA Panel Votes to Recommend Approval for Medtronic’s Amplify Spine Device
– FDA Launches New Initiative to Address Infusion Pump Safety Issues
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