Tonometers – Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

Issue Date: March 27, 2006
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k)
Status: Final

Tonometers – Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff

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).

Download the Guidance Document