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Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities

Mon, 04/25/2011 - 5:30am
U.S. Food & Drug Administration

For questions regarding this guidance document, contact Charles Durfor, Ph.D., at 301-796-6438 or by email at charles.durfor@fda.hhs.gov.

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U.S. Department of Health and Human Services

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

Preface

Public Comment

Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Divisions of Management Systems and Policy, Office of Human Resources and Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to http://www.regulations.gov. All comments should be identified with the docket number listed in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use document number 1582 to identify the guidance you are requesting.

Table of Contents

  1. Introduction
  2. Background
  3. Scope
  4. Device Description
  5. Risks to Health
  6. Sterility
  7. Fire and Explosion Control
  8. Oxygen Pressure Control
  9. Biocompatibility
  10. Electrical Safety Testing
  11. Clinical Studies
  12. Labeling

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.

Warnings

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.


1 Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s.

2 Device Advice: Premarket Notification 510(k).

3 Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA

4 Labeling Reusable Medical Devices For Reprocessing in Health Care Facilities: FDA Reviewer Guidance

5 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

6 General Principles of Software Validation; Final Guidance for Industry and FDA Staff

7 Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices

8 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces #G87-1 #8294)

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.

10 Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment

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.

12 Labeling Reusable Medical Devices For Reprocessing in Health Care Facilities: FDA Reviewer Guidance

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