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FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Date:8/4/2010

the center's review staff obtain the type and level of evidence necessary to make well-supported decisions without as much need for time-consuming follow-up requests for information.
  • The science report recommends use of a standardized "Notice to Industry" letter that would generally be issued as a "Level 1 - Immediately in Effect" guidance document to quickly communicate when CDRH has changed its premarket regulatory expectations due to scientific information that has emerged about a certain device type. CDRH currently communicates this kind of information through individual interactions during the review process, which can lead to delays. These letters would provide greater clarity to affected manufacturers, in a timelier manner, about CDRH's expectations with respect to a particular group of devices.  

  • Improving Patient Safety

    • The 510(k) report recommends that CDRH consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know regarding the safety and effectiveness of the device under review. This is not required now for 510(k) submissions and, as a result, relevant information may not be included in an initial submission. This summary would help CDRH review staff to more efficiently make decisions, and potentially avoid extensive follow-up inquiries and questions.
    • The 510(k) report recommends that CDRH develop a guidance document that clarifies when a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns. The report also recommends that the center consider issuing a regulation that would clarify the circumstances under which the center would exercise its authority to rescind a 510(k) clearance to remove an unsafe device from the market and prec
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    SOURCE U.S. Food and Drug Administration
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