Description
On October 5, 2021, FDA issued a final rule on the De Novo Classification Process. This final rule will add new regulations at 21 CFR Part 860, Subpart D--De Novo Classification that describe the procedures and criteria FDA will use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) contains the information necessary to permit a substantive review. This guidance provides recommendations with further detail regarding the types of information FDA believes are necessary to conduct a substantive review for a De Novo request, as well as recommendations regarding the acceptance review process.
Scope & Applicability
Product Classes
5Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
Low risk medical devices
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
5The person or entity submitting the classification request; The entity responsible for submitting the De Novo request and checklist.; The entity submitting the classification request.
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
FDA staff member responsible for the primary review of the submission.; FDA staff member responsible for the De Novo request.
FDA staff member involved in informal interactions
FDA official consulted for device definition or center assignment issues.; Official consulted for jurisdictional determinations.; Official determining center assignment
Regulatory Context
Attributes
3The timing mechanism for MDUFA performance goals; The timeline tracking the duration of the FDA's review process.
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
conformity with an FDA-recognized standard can help demonstrate that an NGS-based test developer has performed the activities necessary to identify the indications for use; number and types of samples used in the study should be statistically justified for the test’s indications for use; If a modification expands the indications for use beyond aiding in the diagnosis of symptomatic individuals; Acceptable performance levels depend on these
Identified Hazards
Hazards
2Identified risks that special controls must mitigate.
Risks associated with the use of the device that must be identified and mitigated.
Related CFR Sections (9)
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR860.220§ 860.220 De Novo request content.
(a) Unless the requester justifies an omission in accordance with paragraph (c) of this section, a De Novo request must include:Read full regulation →
- 21CFR860.230§ 860.230 Accepting a De Novo request.
(a) The acceptance of a De Novo request means that FDA has made a threshold determination that the De Novo request contains the information necessary to permit a substantive review. Within 15 days after a De Novo request is received by FDA, FDA will notify the requester whether the De Novo request hRead full regulation →
- 21CFR860.210§ 860.210 De Novo request format.
(a) Each De Novo request or information related to a De Novo request pursuant to this part must be formatted in accordance with this section. Each De Novo request must be provided as a single version in electronic format. These materials must:Read full regulation →
- 21CFR860.250§ 860.250 Withdrawal of a De Novo request.
(a) FDA considers a De Novo request to have been withdrawn if:Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
See Also (8)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Status: Final)