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Home » Guidance Threatens Huge Jump In 510(k) Filings, AdvaMed Warns
Guidance Threatens Huge Jump In 510(k) Filings, AdvaMed Warns
October 28, 2011
The FDA stands to receive 300 to 500 percent more 510(k) submissions if the agency implements a draft guidance on when to file a 510(k) for a change to an existing device, AdvaMed says.