Guidance for Industry and FDA Staff

By Effective Medicine  On  In Medical Devices Tagged  

PDF Printer VersionDocument issued on: July 20, 2011

For questions regarding this document contact Richard Felten at 301-796-6392 by email at [email protected].

CDRH Logo

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

General 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 Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, 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 notice of availability that publishes 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 also send an email request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1701 to identify the guidance you are requesting.

Table of Contents

  1. Introduction
  2. Background
  3. Scope
  4. Device Description
    • Device Components
    • Photograph or Drawing of the Device
    • Comparison to the Predicate Device
  5. Risks to Health
  6. Bench Testing
  7. Software Validation
  8. Animal Testing
  9. Clinical Testing
  10. Biocompatibility
  11. Electromagnetic Compatibility (EMC)
  12. Electrical and Mechanical Safety Performance Testing
  13. Labeling
    • Device User Manual
    • Directions for Use
    • Indications for Use
    • Contraindications
    • Storage Conditions
    • Warnings
    • Precautions
  • Appendix A

Guidance for Industry and FDA Staff

Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use

1. Introduction

This guidance document was developed as a special control guidance to support the classification of the focused ultrasound stimulator system for aesthetic use into class II (special controls). The device is intended to apply focused ultrasound energy to the body to achieve temporary changes in physical appearance. This guidance document is issued in conjunction with a Federal Register notice announcing the classification of the focused ultrasound stimulator system for aesthetic use.

Following the effective date of the final rule, manufacturers of devices within this generic type of device will need to address the issues covered in the special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

2. Background

FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the focused ultrasound stimulator system for aesthetic use. Therefore, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug Cosmetic Act (FDC Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with the focused ultrasound stimulator system for aesthetic use, including those identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device.

This special control guidance document identifies the classification regulation and product code for the focused ultrasound stimulator system for aesthetic use (refer to Section 3. Scope). Other sections of this guidance document list the risks to health FDA has identified and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these focused ultrasound stimulator systems and lead to a timely 510(k) review. This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission. You should also refer to 21 CFR 807.87, the guidance, Format for Traditional and Abbreviated 510(k)s1 and the section of CDRH’s Device Advice, Premarket Notification Submission 510(k).2

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.3 The kind of information we recommend you submit is determined by the “level of concern,” which is related to risks associated with software failure. The level of concern for a device may be minor, moderate, or major. FDA believes that the software used to operate the device presents a “moderate level of concern” as described in the Software Guidance because a failure or latent design flaw could directly result in minor injury to the patient or operator.

In addition, we recommend that the development of the control software follow IEC 60601-1-4: Medical electrical equipment – Part 1-4; “General Requirements for Safety; Collateral Standard: Programmable electrical medical devices” or equivalent methods.

4 FDA also requires that animal studies to support marketing and research applications are conducted in compliance with Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58).

5 In addition to the requirement of having an FDA-approved IDE, sponsors of such trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).

6

Device User Manual

We recommend that you provide a user manual with the device. The user manual should include descriptions of:

  • the device and all accessories
  • how the device interconnects with other components or accessories
  • all features, functions, output modalities, and specifications
  • all user-accessible controls
  • indicators, markings, and/or labels on the device which provide information regarding the function or meaning of each control, display output jack, etc.
  • illustrations of the device and accessories
Directions for Use

As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate directions for lay use. Labeling must include, however, adequate information for 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)).

Indications for Use

We recommend that the indications for use be included in the user manual.

Contraindications

We recommend that you advise users with open wounds or lesions, including severe or cystic acne, active implantables (e.g., pacemakers or defibrillators), or metallic implants not to use the device in these areas.

Storage Conditions

We recommend that storage conditions be included in the user manual.  

Warnings

Should describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur.

Should include an appropriate warning if there is reasonable evidence of an association of a serious hazard with the use of the device. A causal relationship need not have been proved.

Should include a warning to ensure complete handpiece skin contact and to not expose the eyes to ultrasound radiation.

We believe a warning is appropriate when the device is commonly used for disease or condition for which there is a lack of valid scientific evidence of effectiveness for that disease or condition and such usage is associated with a serious risk or hazard.  

Precautions

Should include information regarding any special care to be exercised by the practitioner and/or patient for the safe and effective use of the device, for example:

  • Should indicate or emphasize any need for protective wear during use.
  • Should identify any laboratory tests or other evaluations that may be helpful in following the patient’s response or identify adverse reactions and, if appropriate, specify the frequency of such tests or evaluations before, during and after use of the device.
  • Should identify any precautions to help prevent electrical shock, such as any need for specific device placement, appropriate electrical wiring needs, reminders to periodically check device wiring and accessories for damage, and avoidance of use of the device in environments where electrical shock is possible.

Appendix A

As stated in Section 9, the conduct of preclinical animal studies should follow modern practices of humane care and use. All animal studies should be designed based on the modern practices described in the following references.

  1. Animal Welfare Act, Code of Federal Regulations, Title 9 Volume 1, 7 USC 2131-2156
  2. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Protection from Research Risks, NIH, Bethesda, MD, 1996: http://grants.nih.gov/grants/olaw/references/phspol.htm
  3. Public Law 99-158 “Animals in Research” Health Research Extension Act of 1985 November 20, 1985. http://grants.nih.gov/grants/olaw/references/phspol.htm#Health%20Research%20Extension%20Act%20of%201985.
  4. US Government Principles for the Utilization of and Care of Vertebrate Animals Used in Testing, Research, and Training. http://grants.nih.gov/grants/olaw/references/phspol.htm#USGovPrinciples.
  5. Guide for the Care and Use of Laboratory Animals. National Research Council, Institute of Laboratory Animal Resources Commission on Life Sciences 1996. National Academies of Science Press, Washington, DC. http://www.nap.edu/openbook.php?record_id=5140page=8

1Format for Traditional and Abbreviated 510(k)s

2Premarket Notification 510(k)

3Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

4 ANSI/AAMI/ISO 10993-2:2006: Biological evaluation of medical devices – Part 2: Animal welfare requirements
And
Russell, W.M.S. and Burch, R.L., The Principles of Humane Experimental Technique. Methuen, London, 1959. Reprinted by UFAW, 1992: 8 Hamilton Close, South Mimms, Potters Bar, Herts EN6 3QD England. ISBN 0 900767 78 2

5 For additional information regarding clinical trial requirements, see Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.

6 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. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.


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