The 510(k) clearance pathway, or premarket notification process, which provides “fast-track” approval has recently drawn criticism for leniency, according to the report. The premarket notification process does not require the same level of evidence as premarket approval, which makes 510(k) clearance faster and less costly.
Device makers fear that tightening the process could slow innovation to the marketplace and make it more difficult for smaller device companies to compete in the market because of the increased time and costs associated with approval.
In September, the FDA asked the Institute of Medicine to review the 510(k) process, and the review is expected to be complete by March 2011. The FDA has also formed an internal group to review the process, according to the report.
Read the Wall Street Journal’s report on 510(k) clearance.
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