Description
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amended the Federal Food, Drug, and Cosmetic Act (the act) by authorizing FDA to collect user fees for certain premarket submissions received on or after October 1, 2002. A letter from the Secretary of Health and Human Services to Congress that accompanies the user fee legislation sets forth performance goals and policy and procedural provisions. One of these provisions is entitled, “Bundling Policy,” and states that FDA will consider, in consultation with its stakeholders, when bundling multiple devices in a single submission may be appropriate.
Scope & Applicability
Product Classes
6IVDs mentioned regarding clinical decision-making impact
SUDs mentioned in the context of bundling submissions; MDUFMA provides new regulatory requirements for reprocessed SUDs.
Products explicitly excluded from the scope of this guidance
Low risk medical devices
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Generally 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.
Stakeholders
3entity submitting marketing applications
Designs of SUDs may be unique to different OEMs.
FDA contact for modular review steps
Regulatory Context
Attributes
1Fees required for the review of certain premarket submissions.
Related CFR Sections (4)
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 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 →
- 21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
See Also (8)
- Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff (Status: Final)
- Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 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)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)