Description
Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21)
Scope & Applicability
Product Classes
5continuous home use ventilators require tracking
Example of a device requiring predicate selection
Concepts in the guidance may be applied to these devices.
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.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Stakeholders
2Entities that introduce devices into commercial distribution
Entity responsible for submitting NDINs
Regulatory Context
Attributes
1is a life sustaining or life supporting device used outside a device user facility.
Identified Hazards
Hazards
1Condition that triggers the need for tracking to facilitate notification and recall.
Related CFR Sections (3)
- 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 →
- 21CFR821.30§ 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.
(a) A distributor, final distributor, or multiple distributor of any tracked device shall, upon purchasing or otherwise acquiring any interest in such a device, promptly provide the manufacturer tracking the device with the following information:Read full regulation →
- 21CFR821.25§ 821.25 Device tracking system and content requirements: manufacturer requirements.
(a) A manufacturer of a tracked device shall adopt a method of tracking for each such type of device that it distributes that enables a manufacturer to provide FDA with the following information in writing for each tracked device distributed:Read full regulation →
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (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)
- Time and Extent Applications for Nonprescription Drug Products (Status: Final)
- Medical Device Tracking : Guidance for Industry and FDA Staff (Status: Final)