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Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers

This guidance document, issued by FDA on April 19th, supersedes Draft Guidance on Medical Device Patient Labeling from March 3rd.

The purpose of this guidance is to assist manufacturers in their development and the Center reviewers in their review and evaluation of medical device patient labeling to help make it understandable to and usable by patients or lay caregivers. The writing style is targeted to manufacturers, since they will be developing the medical device patient labeling.

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. You will find in the guidance the general type of information that may be included in medical device patient labeling (see p. 6 of 51), as well as examples illustrating situations where you should consider developing patient labeling (see p. 7 of 51) and when it is not necessary (see p. 8 of 51). This document also provides an answer to what you should consider when identifying a method to distribute the medical device patient labeling (see p. 9 of 51).

The table of content with glossary is divided into four parts: descriptive (see p. 11 of 51), operating (see p. 15 of 51), troubleshooting (see 18 of 51) and additional information (19 of 51).

An important note: Not all of the headings suggested in this paper apply to all medical device labeling.

Please also be aware that at the beginning of this document, the FDA has a boldly marked disclaimer, stating, "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."

For more information about this guidance document, please, visit the FDA's Web site at: www.fda.gov/cdrh/ohip/guidance/1128/html or contact mdi's office at: info@mdiconsultants.com

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