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

Description

The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2022, including De Novo classification requests (De Novo requests). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR860.250§ 860.250 Withdrawal of a De Novo request.

  (a) FDA considers a De Novo request to have been withdrawn if:Read full regulation →

• 21CFR860.260§ 860.260 Granting or declining a De Novo request.

  (a)Read full regulation →

• 21CFR860.240§ 860.240 Procedures for review of a De Novo request.

  (a) FDA will begin substantive review of a De Novo request after the De Novo request is accepted under § 860.230 . Within 120 days after receipt of a De Novo request or receipt of additional information that results in the De Novo request being accepted under § 860.230 , FDA will review the De Novo Read full regulation →

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• 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.

  2025-08-26

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Clinical Investigator

  Americo F. Padilla, M.D.

  2025-03-25

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  Mid-Link Testing Company, Ltd

  2024-09-11

• 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)
• Acceptance Review for De Novo Classification Requests: 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)
• 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)