De Novo Classification Process (Evaluation of Automatic Class III Designation)

The ICR describes the information collection involved with the De Novo classification process for medical devices. FDA uses the information in the De Novo request to evaluate whether the medical device may be reclassified from Class III to Class I or II, and if applicable, to determine the general and/or special controls necessary to sufficiently regulate the medical device. Respondents to the information collection are medical device manufacturers.

The latest form for De Novo Classification Process (Evaluation of Automatic Class III Designation) expires 2022-08-31 and can be found here.

De Novo request under 21 U.S.C. 513(f)(2)(i)

Federal Enterprise Architecture: Health - Consumer Health and Safety