This Draft Guidance Document provides information directed to the review of electrocardiograph surface electrode testers (ECG electrode testers). This guidance should assist in determining whether the device submission has addressed design, testing, and labeling issues sufficiently to establish a basic level of safety, effectiveness, and substantial equivalence to predicate devices.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.