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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 310.100 Pacemaker Reuse March 1995

Final
Docket Number:
FDA-2013-S-0610
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Office of Regulatory Affairs

BACKGROUND:

The *Center for Devices and Radiological Health* has learned of the possible re-use of cardiac pacers. *Center* medical experts have studied this situation and have determined that there is a serious question whether pacemakers can be properly re-sterilized following initial implantation due to the possibility of body fluids entering the terminal leads of the pacemaker. This also poses the problem of foreign protein matter to the second recipient.

POLICY:

Pacemaker re-use is an objectionable practice. Anyone learning of the re-use of pacemakers should obtain and submit complete information to *HFZ-300* for review and evaluation.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/95


Submit Comments

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-2013-S-0610.

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