Zdrowie i gospodarka · 19.04.2001

Guidance on Medical Device Patient Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled "Guidance on Medical Device Patient Labeling." This guidance describes how to make medical device patient labeling understandable to and usable by patients (or family members or other lay persons caring for patients). It is intended to assist manufacturers in their development and reviewers in their review and evaluation of medical device patient labeling. This guidance is designed to help assure safe and effective use of medical devices through medical device patient labeling that informs patients or their lay caregivers about proper use, risks, and benefits of the device in language they can understand.