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Home » FDA says the refuse-to-accept rate for dental device 510(k)s greater than 80%
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FDA says the refuse-to-accept rate for dental device 510(k)s greater than 80%

Oct. 25, 2019
By Mark McCarty
Dental devices would likely strike most observers as fairly simple items, but an FDA employee said on a recent webinar that these filings have a refuse-to-accept (RTA) rate in excess of 80%, suggesting sponsors have a lot of regulatory homework to do. The FDA finalized the RTA policy for 510(k) devices in September 2019, wrapping up a draft that originated in 2012, but which is on the second iteration.
BioWorld MedTech Regulatory 510(k) FDA

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