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Guidance on Medical Device Patient Labeling. PDF Printer Version(3. KB)Document issued on: April 1. This document supersedes Draft Guidance on Medical Device Patient Labeling, March 3, 2.
U. S. Department Of Health and Human Services. Food and Drug Administration.
Center for Devices and Radiological Health. Labeling Research and Policy Development Branch. Division of Device User Programs and Systems Analysis. Office of Health and Industry Programs. Preface. Public Comment. 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, 5. Fishers Lane, Room 1.
HFA- 3. 05), Rockville, MD, 2. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance contact Paula Silberberg at 3. Additional Copies. Additional copies are available from the Internet. Table of Contents.
Introduction. What is the purpose of this guidance. What is medical device patient labeling? Why is medical device patient labeling important?
What are the general types of information that may be included in medical device patient labeling? When should you use medical device patient labeling? When is medical device patient labeling not usually necessary? What should you consider when identifying a method to distribute the medical device patient labeling? Suggested Content of Medical Device Patient Labeling: Determining Sequence and Content: Table of Contents: Glossary: Descriptive Information: Purpose of the device (indications for use): Description of the device: When the device should not be used (contraindications): Risks and benefits: Expectations of the device and the procedure associated with the device: General warnings and precautions: Importance of the need to adhere to a care regimen: Operating Information: Setup instructions: Checkout procedures: Operating instructions: Importance of the need to monitor the activity of the device: Cleaning instructions: Description of maintenance and who should do it: Storage instructions: Expected failure time and mode and its effect on the patient: Instructions on how to safely dispose of the device: Instructions on accessories: Instructions on related, additional devices: Troubleshooting Information: Troubleshooting: Additional Information: Clinical studies: Disease and self- care information: Adverse events: Warranty: Travel or international use: Index: Date of Printing: User Assistance Information: Appendix AReadability: Appendix B Writing for increased comprehension: Appendix C Appearance of text: Appendix D Appearance of graphics: Appendix EWarnings and precautions: Appendix FPretesting: Checklist Summary: References: Sequence: Risks and benefits: Additional Information: User Assistance Information: Readability: Writing for increased comprehension: Appearance of text: Appearance of graphics: Warnings and precautions: Pretesting: Usability testing: Guidance on Medical Device. Patient Labeling. This document is intended to provide guidance.
It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. Back to Top. Introduction: What is the purpose of this guidance? This guidance serves a dual purpose: to assist manufacturers in their development, andto assist Center reviewers in their review and evaluationof medical device patient labeling to help make it understandable to and usable by patients (or family members or other lay persons caring for patients). The writing style we have adopted in this guidance is targeted to manufacturers, since they will be developing the medical device patient labeling. When translating the professional label into lay language, take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or other parts of the professional labeling.
The lay translation should also provide a balanced presentation of adverse events and the risks and benefits of the device. It should not introduce new claims that are not in the professional label. Device labeling evolves throughout the review process. Therefore, it is your responsibility to ensure that the patient label is consistent with the final professional label. What is medical device patient labeling? Medical device patient labeling is any information associated with a device targeted to the patient or lay caregiver.
It is intended to help assure that the device is used safely and effectively. This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices. Medical device patient labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes.
This labeling is intended to be supplied, or given to and used by patients or their lay caregivers with or without accompanying professional counseling. Medical device patient labeling may accompany devices intended solely for physicians to operate, devices for both physicians and patients or lay caregivers to operate, and devices operated solely by patients or their lay caregivers. Why is medical device patient labeling important? Medical device patient labeling is essential to assure safe and effective use of many, but not all, devices. It informs patients or their lay caregivers about proper use, risks, and benefits of the device in language they can understand. Medical device patient labeling assists patients or their lay caregivers in understanding the device; its operation, care, and maintenance; the way it interacts with the body to accomplish its purpose; its place and purpose in the patient care regimen; and any safety or disposal issues.
Patient labeling is important for all devices operated by lay users. Adequate directions for operating the devices are needed to make devices safe and effective. For example, as more patients use complex medical devices at home, medical device patient labeling becomes necessary to better communicate to the lay person how to operate the device.
What are the general types of information that may be included in medical device patient labeling? There are two general categories of information that may be included in medical device patient labeling: risk/benefit information; andinstructions for use. Risk/benefit information is information people need to decide to use a device or have it used on them. This information also allows the users to become aware of potential problems with the device.
It might include, as appropriate to the device: sufficient descriptive information to tell what the device is and what it is used for,types of people and situations for whom the device would not be a good choice,risks and benefits to the patient or environment associated with the uses of the device,information about maintaining the device or identifying potential problems with the device,alternative therapeutic and diagnostic choices available, and/orother information to enable the person to make an informed decision about the device. Devices that would have patient labeling consisting primarily or completely of risk/benefit information might be: implants that have no external patient interface once they are implanted, or prescription diagnostic or therapeutic devices that the patient is actively involved in choosing (e. Instructions for Use are the procedural steps to follow in setting up, using, cleaning, troubleshooting, and storing a device. This information constitutes the . They might include such devices as suction equipment, intravenous infusion pumps, physical therapy equipment, or transdermal electrical nerve stimulation (TENS) devices. There are many types of medical devices for which the medical device patient labeling would have both risk/benefit and instructions for use information.
When should you use medical device patient labeling? Medical device patient labeling should be supplied whenever it can benefit patients or lay caregivers. Patients or lay caregivers benefit from this labeling by increasing their knowledge about the device. Knowledgeable users are more likely to use the device as you intend. You should know the informational needs of your target audience in order to determine if patient labeling is necessary. Does your audience need or want specific information? Is there something unique about the device (e.
Does your audience already know the information? The following examples illustrate situations where you should consider developing patient labeling. The situations are grouped into risk/benefit information and instructions for use. You should consider developing risk/benefit information when patients or lay caregivers need to: give personal health information to aid their health care practitioner in deciding to use or not use devices in prevention, treatment, or diagnosis of an illness (e. MRI)); select among similar devices or device procedures; be involved in deciding whether to have a procedure involving the device; and/orunderstand the effect or influence of the device on the patient or others (e.
You should consider developing instructions for use when patients or lay caregivers need to: monitor and report on the operation or output of the device (e. You should consider developing both risk/benefit information and instructions for use when patients or lay caregivers need to: operate, interpret, and manipulate the device (e.
When is medical device patient labeling not usually necessary? Medical device patient labeling is not usually necessary when: a patient will have no opportunity to benefit from the labeling. The following are typical situations.