Description
This guidance documentdescribes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees.
Scope & Applicability
Product Classes
3Products 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.
Subject of performance standard review
Devices for vulnerable patient populations
Stakeholders
7Assists in clarifying issues and mediating meetings; Engaged prior to filing a formal request for review or for bias allegations
Entity responsible for receiving written comments on the guidance.
Decision maker in expedited withdrawal procedures; Provides opportunity for a meeting or written appeal during withdrawal procedures.; FDA Commissioner or their designee presiding over appeals
External individuals providing advice to the review authority
Qualified individuals participating on Advisory Committees
Official who investigates concerns regarding DRP panel members; Point of contact for special circumstances in appeals
DRP convened for center-level reviews
Regulatory Context
Attributes
1Decisions defined under Section 517A subject to specific timelines
Related CFR Sections (7)
- 21CFR10.25§ 10.25 Initiation of administrative proceedings.
An administrative proceeding may be initiated in the following three ways:Read full regulation →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
- 21CFR10.33§ 10.33 Administrative reconsideration of action.
(a) The Commissioner may at any time reconsider a matter, on the Commissioner's own initiative or on the petition of an interested person.Read full regulation →
- 21CFR10.35§ 10.35 Administrative stay of action.
(a) The Commissioner may at any time stay or extend the effective date of an action pending or following a decision on any matter.Read 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 →
- 21CFR800.75§ 800.75 Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health.
(a) Definitions. The following definitions shall apply to this section: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)
- Evaluation of Therapeutic Equivalence (Status: Draft)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21) (Status: Final)
- Guidance for Industry: Seafood HACCP Transition Guidance (Status: Final)
- Guidance for Industry: Implementation of Section 10809 of the Farm Security and Investment Act of 2002 Regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated with Irradiation (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff (Status: Final)
- User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide - Guidance for Industry (Status: Final)