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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 310.100 Pacemaker Reuse March 1995

Final

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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.