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Appendix B
Contains Nonbinding RecommendationsAcceptance Checklist
for Abbreviated 510(k)s
(Should be completed within 15 days of DCC receipt)
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What is for abbreviated 510ks?
Abbreviated 510ks are a type of premarket notification submission for medical devices that demonstrate substantial equivalence to a legally marketed device (predicate device).
Who is required to file for abbreviated 510ks?
Manufacturers who intend to market a new medical device that is substantially equivalent to a previously cleared device must file for abbreviated 510ks.
How to fill out for abbreviated 510ks?
Abbreviated 510ks should be filled out with information on the new medical device, comparison to a predicate device, and supporting data to demonstrate substantial equivalence.
What is the purpose of for abbreviated 510ks?
The purpose of abbreviated 510ks is to provide a streamlined pathway for new medical devices that are substantially equivalent to existing devices to come to market.
What information must be reported on for abbreviated 510ks?
Information on the new device, comparison to a predicate device, data supporting substantial equivalence, and any additional information requested by the FDA must be reported on abbreviated 510ks.
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