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GUIDANCE DOCUMENT

Tonometers - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff March 2006

Final

Tonometers - Premarket Notification [510(k)] Submissions

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this guidance document to assist industry in preparing premarket notification submissions for contact and non-contact tonometers. The device is intended for measuring intraocular pressure (IOP).


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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.