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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .
This guideline describes a general framework for design verification testing of a safe and effective implantable cardiac pulse generator. The tests are designed to reasonably assure safe and effective functioning of the pacemaker in the patient, according to written specifications of performance, and its survival under expected environmental conditions in the body and during storage, shipping and handling.
This guideline is intended to apply-to bradycardia pacemakers which are to be commercially marketed and are manufactured using standard production techniques and methods. It may not apply to devices which are used in limited research applications. Major variations from these guidelines may be warranted in some cases such as the latter. Some devices may be qual if ied in whole or in part by simi larity to previously qualified ones. In all cases arguments for any variations must be made based on the nature of the mission of the device and on any claimed similarities.
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-2020-D-0957.