For questions regarding this guidance document, contact Charles Durfor, Ph.D., at 301-796-6438 or by email at firstname.lastname@example.org.
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health
Food and Drug Administration
Center for Devices and Radiological Health
Plastic and Reconstructive Surgery Devices Branch Division of Surgical Orthopedic, and Restorative Devices Office of Device Evaluation
Division of Surgical Orthopedic, and Restorative Devices
Office of Device Evaluation
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Table of Contents
- Device Description
- Risks to Health
- Fire and Explosion Control
- Oxygen Pressure Control
- Electrical Safety Testing
- Clinical Studies
Guidance for Industry and FDA Staff
Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities
The 510(k) must include proposed labels and labeling in sufficient detail to describe the device, its intended use, and the directions for its use. 21 CFR 807.87(e). If applicable, photographs or engineering drawings should be supplied. 21 CFR 807.87(e). The following suggestions are aimed at assisting you in preparing final labeling that satisfies the requirements of 21 CFR Part 801.11
Directions for Use
TOCE is a prescription device under 21 CFR 801.109. As a prescription device, a TOCE is exempt from having adequate directions for lay use. Labeling that furnishes or purports to furnish information for use of the device must include, among other information, adequate information for safe and effective practitioner use of the device, including indications, effects, routes, methods, frequency and duration of administration and any relevant hazards, contraindications, side effects and precautions. 21 CFR 801.109(d). See 21 CFR 801.109 for additional labeling requirements for prescription devices.
Labeling should provide instructions for cleaning and disinfecting or sterilizing the device after each use. Refer to Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance.12 Such information can include, but may not be limited to:
- pre-processing device handling methods (e.g., addressing biohazard concerns),
- disassembly/reassembly methods,
- cleaning methods,
- cleaning/lubricating agents,
- rinsing techniques,
- disinfection or sterilization methods,
- special post-process handling,
- reuse life, and
- warnings and precautions.
Labeling should also describe methods for venting oxygen from the TOCE to control the risk of fire or explosion.
Labeling should warn that inadequate cleaning and disinfection or sterilization of the device after use may lead to transmission of infectious disease.
The label on the device should warn that inappropriate venting of oxygen from the TOCE can lead to fire or explosion.
9 At the time FDA issued this guidance, FDA has not cleared TOCE devices for indications of improved incidence of wound healing or the prophylaxis or treatment of wound infection or pain reduction.
11 Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. Final labeling for prescription medical devices must also comply with 21 CFR 801.109. Labeling recommendations in this guidance document are consistent with the requirements of Part 801.