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In 2012, section 513 (f) (2) of the FD&C act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), to provide a second option for De Novo...
De Novo: De novo provides a possible route to classify novel devices of low to moderate risk. This database contains de novo classification orders. Weekly Devices@FDA
The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety...
Evaluation of Automatic Class III Designation (De Novo) Summaries; Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed...
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The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA proposed a new rule to implement a De Novo Classification Process and define the scope of regulatory procedures when classifying and reclassifying medical devices.
De Novo Classification Process (Evaluation of Automatic Class III Designation) On October 5, 2021, FDA issued a final rule on the De Novo Classification Process. The final rule added new regulations at 21 CFR Part 860, Subpart D--De Novo Classification, and is effective 90 days after publication.
For devices that have already undergone 510 (k) review, FDA will consider a De Novo request if the device has been determined to be NSE due to: (1) the lack of an identifiable predicate device, (2) a new intended use, or (3) different technological characteristics that raise different questions of safety and effectiveness.
Since 2010, the FDA has released summary documents for devices classified through the De Novo process. The De Novo summary is intended to present an objective and balanced summary of the...