Medical Device Link.

Originally Published May 2000

REGULATORY FOCUS

New Format for Device Labeling

Until now, there were no mandates on formatting medical device patient labeling. However, in an attempt to make such labeling easy for patients to understand, FDA has published a draft guidance.

The Center for Devices and Radiological Health (CDRH) issued the document, "Guidance on Medical Device Patient Labeling," on March 3, 2000. It aims "to assist manufacturers in their development and assist center reviewers in their review and evaluation of medical device labeling to help make it understandable to and usable by patients . . . or lay persons caring for patients."

The document can be viewed at http://www.fda.gov/cdrh/humfac/1128.pdf (in PDF).

Clearer labeling is needed, the agency says, because more patients use complex devices at home and may not understand their proper uses, risks, and benefits if labeling is written in technical jargon.

The guidance will apply to all devices, except to those where the patient has no opportunity to benefit from the labeling. Exemptions include instances in which the patient has no control over the device, no access to it, or no choice in its selection and instances in which the patient cannot provide useful information to the healthcare practitioner to help him or her choose the device.

The main things that must be included in device labeling, FDA says, are risk/benefit information and instructions for use. With that in mind, the agency proposes the following structure:

• A table of contents.
• A description of the device's approved indications.
• A description of the device itself, including all parts and accessories.
• A list of contraindications explaining when the device should not be used.
• A list of risks and benefits associated with the device or procedure "in a manner that is meaningful to the user."
• A list of what to expect before, during, and after device use.
• A list of general warnings and precautions.
• A statement of why it is important to follow the care regimen as listed in the instructions.
• References to device and treatment alternatives.
• A list of clear setup instructions.
• A list of clear checkout procedures.
• A list of clear and easy-to-follow operating instructions.
• A statement of the importance of monitoring the device's activity.
• A list of clear and complete cleaning instructions.
• A description of device maintenance and an explanation of who should perform it if not the user.
• A list of clear storage instructions.
• A statement of how long the device is supposed to last, what happens when it fails, and what effect that failure has on the patient.
• A set of clear instructions about accessories.
• A set of instructions about any related or supplementary devices being used in conjunction with the primary one.
• An easy-to-find troubleshooting section, formatted so the user can locate specific problems quickly.
• Optional additional information, from clinical studies and their adverse events to travel and international use considerations.
• An index or glossary.
• The date the labeling was issued or revised.
• A clearly marked section that advises users on how to obtain help for device problems. Focus-group research showed that patients preferred this information at the end of the labeling. It can be placed elsewhere in addition to the end.

The guidance calls for manufacturers to use a 12-point type size whenever possible, preferably a larger one if the target audience is elderly or visually impaired. It also suggests a serif font, a left-justified margin, text using uppercase and lowercase letters, black type on a white background, and at least 1/16 in. of white space between lines of text.

The document contains appendices with extensive suggestions on, among other things, how to write the labeling so that everyone can understand it clearly, how to organize graphics, how to present warnings and precautions, and how to test the audience's reaction to the proposed labeling before it is published.

A 90-day public comment period on the draft document will end June 1. Comments should be submitted to Docket No. 00D-0785, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, FDA, 5630 Fishers Ln., Rm. 1061, (HFA-305), Rockville, MD 20852.