- Docket Number:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance serves a dual purpose:
(1) to assist manufacturers in their development, and
(2) to assist Center reviewers in their review and evaluation of 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2000-D-0067.