Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published January 1998

REGULATORY FOCUS

Comment Period Closes for Medical Device Labels

Now that the deadline has passed, CDRH can finalize labeling guidelines for new devices.

The comment period is over for FDA's draft guidance on medical device labeling. Intended for devices cleared through premarket approval (PMA) or premarket notification (510k) submissions, the new document will supersede the labeling requirements found in the blue-book memorandum #G91-1.

The document was written because, in FDA's view, the blue book memo is only an overview of labeling and does not give specific guidance. Since labeling is an important consideration in FDA clearance of PMA applications and 510(k) submissions, the Center for Devices and Radiological Health (CDRH) prepared the draft guidance document, which it issued for comments on April 25, 1997.

The guidance document explains key labeling terms such as warnings, precautions, contraindications, and adverse events. It also describes essential label elements and prescribing information for medical devices.

Compliance with the draft guidance is not mandatory. However, FDA regards the document as an explanation of its views and policies regarding labeling, and inspectors will base decisions on it. Manufacturers should understand its recommendations.

IN PRINCIPLE

The draft guidance states that all product packages (except those for surgical instruments) should bear a label that includes the name of the device and the manufacturer as well as the manufacturer's address. The proposal lists 14 types of "essential prescribing information" sections that may or may not be needed for a label, as follows:

Brief Device Description; Intended Use/Indications; Contraindications; Warnings; Precautions; Adverse Events; Clinical Studies; Individualization of Treatment; Patient Counseling Information; Conformance to Standards; How Supplied; Operator's Manual, Patient's Manual; and References.

Certain devices are exempt. The draft guidance does not apply to labeling of in vitro diagnostic products already covered by CFR 809.10. Also, devices having commonly known directions, such as adhesive bandages and tongue depressors, need only a product name and brief description. Device packaging that is too small for all recommended information—rewetting drops for contact lenses, for example—may be minimally labeled as long as a statement refers the user to additional labeling such as an insert or outsert.

In addition, most device labels should contain essential prescribing information. CDRH believes manufacturers communicate more effectively with users when the most important labeling information is organized into a brief, structured abstract. The proposed format is a description not more than one page in length, with icons and illustrations and cross-references to the full labeling.

The draft guidance also spells out a new format for warnings. The label should contain a signal word (such as WARNING  or CAUTION ) followed by a hazard avoidance directive (beginning with such words as Do not, Never, or Avoid ), an identification of the hazard, and a description of the consequences if the warning is not observed.

Manufacturer reaction to the draft guidance document has been favorable, according to the Association for the Advancement of Medical Instrumentation (AAMI), with the exception of some who feel the document would lead to an unnecessary increase in labeling volume and cost without a corresponding increase in usefulness.

Comments from a September 5, 1997, meeting are being evaluated by CDRH. When the draft guidance document has been finalized, copies will be available through AAMI. Contact the association at 703/525-4890 or through its Web site, http://www.aami.org. A copy of the draft guidance may be downloaded at http://www.fda.gov/cdrh/ode/labeling.html.