OMB control number
De Novo Classification Process (Evaluation of Automatic Class III Designation)
OMB 0910-0844 · HHS/FDA.
OMB 0910-0844
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 2028-04-30 and is listed under ICR 202404-0910-004.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0844_Supporting Statement_2024.docx | Supporting Statement A |
 De Novo requests |
Other-De Novo Classification Process (Evaluation of Automatic Cl |
| Withdrawal of de novo request |
Other-De Novo Classification Process (Evaluation of Automatic Cl |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202404-0910-004 | Revision of a currently approved collection | 2025-01-03 | ||
| 202111-0910-009 | Revision of a currently approved collection | 2021-12-02 | Approved without change | |
| 201905-0910-006 | Revision of a currently approved collection | 2019-07-11 | Approved without change | |
| 201904-0910-011 | Revision of a currently approved collection | 2019-04-17 | Comment filed on proposed rule and continue | |
| 201707-0910-009 | New collection (Request for a new OMB Control Number) | 2017-08-03 | Approved without change |
OMB Details
Withdrawal of de novo request
Federal Enterprise Architecture: Health - Consumer Health and Safety