Description
The Medical Device User Fee Amendments of 2022 (MDUFA V), amended the Federal Food, Drug, and Cosmetic Act (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 premarket approval applications (PMAs) and certain biologics license applications (BLAs). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the medical device review process to meet certain performance goals and implement improvements for the medical device review process as outlined in the letter from the Secretary of Health and Human Services to Congress.
Scope & Applicability
Product Classes
2Devices requiring a premarket report
PMA type where fee is paid upon first module submission
Stakeholders
3PMA applicant entering a licensing agreement
The Secretary has sole discretion to refund fees
Party receiving permission to reference PMA data
Regulatory Context
Attributes
2Fees required for the review of certain premarket submissions.
Electronic copy requirement for medical device submissions
Related CFR Sections (5)
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
- 21CFR814.82§ 814.82 Postapproval requirements.
(a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR814.44§ 814.44 Procedures for review of a PMA.
(a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42 . FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously revieweRead full regulation →
See Also (8)
- Suggested Format For IDE Progress Report (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff (Status: Final)