Description
Section 302 of Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA), created Section 515A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e-1). Section 515A requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemptions (HDEs), and product development protocols (PDPs) for new devices to include readily available information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure.
Scope & Applicability
Product Classes
1Medical devices intended for human use; Approved or cleared medical devices
Stakeholders
2participate in the ASCA Pilot
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
4Estimated number of people with a disease, used to determine clinical investigation enrollment.
A metric used in calculating population estimates for designations.
Required data for pediatric population estimates
The type of pediatric use information required for submissions
Related CFR Sections (2)
- 21CFR814.3§ 814.3 Definitions.
For the purposes of this part:Read 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 →
See Also (8)
- Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff (Status: Final)
- Pyrogen and Endotoxins Testing: Questions and Answers (Status: Final)
- Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff (Status: Final)
- User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff (Status: Final)