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FDAnews Device Daily Bulletin
May 10, 2012 | Vol. 9 No. 93
Reconstructing 510(k) Decisions Key to New Guidance
CINCINNATI — Fears over a draft guidance on submitting 510(k)s for product alterations may be overblown, but industry and regulatory experts agree it changes the status quo. The draft, which would replace 1997 guidance, was issued in August and widely criticized on the grounds it would increase the paperwork burden on devicemakers. AdvaMed estimated it could spark a 300 percent to 500 percent increase in 510(k) filings.
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