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GUIDANCE DOCUMENT

Labeling for Electronic Anti-Theft Systems Guidance for Industry August 2000

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this letter is to recommend that all manufacturers of electronic anti-theft systems develop labeling or signage to post on or near all new and currently installed systems, indicating that an electronic anti-theft system is in use. Such labeling or signage will permit implant wearers to avoid lingering around or leaning against systems that may affect their implanted electronic medical devices

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Submit Comments Online

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:

Dockets Management
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-2020-D-0957.

 
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