Description
This guidanceis intended to help manufacturers of medical products that contain natural rubberlatex, the majority of whom are small businesses.This guidanceaddresses specific federalregulations for labeling medical products that contain natural rubber latex.This guidancedoes notapply to products made from synthetic latex or synthetic rubber that do not include natural rubber intheir formulations.
Scope & Applicability
Product Classes
2FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Products subject to the unique device identification system
Stakeholders
4Includes patients, healthcare providers, specialized professionals, and consumers.; Includes patients, healthcare providers, specialized professionals, lay users, consumers
Way questions are framed is critical to collecting unbiased patient input
Establishments whose size and resources are considered in RRA timeframes.
manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws
Regulatory Context
Attributes
1Condition where rubber is intended to or likely to contact user/patient
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 →
- 21CFR801.437§ 801.437 User labeling for devices that contain natural rubber.
(a) Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and protecRead 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)
- Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff (Status: Final)
- Time and Extent Applications for Nonprescription Drug Products (Status: Final)
- Medical Device Tracking : Guidance for Industry and FDA Staff (Status: Final)