Description
This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Scope & Applicability
Product Classes
2IVDs for emerging pathogens during a Section 564 declared emergency
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Stakeholders
2FDA may seek advice when considering the initiation or progress of a PAS
Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
Regulatory Context
Attributes
2limits the exemption to prescription battery powered devices
Cybersecurity is part of device safety and effectiveness
Related CFR Sections (2)
- 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 →
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
See Also (8)
- 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)
- User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide - Guidance for Industry (Status: Final)
- Time and Extent Applications for Nonprescription Drug Products (Status: Final)
- Medical Device Tracking : Guidance for Industry and FDA Staff (Status: Final)