The FDA has issued guidance for industry and FDA staff on premarket notification for 510K submissions for tonometers.
The FDA developed the guidance to assist industry in preparing premarket submissions for contact and non-contact tonometers, used for measuring intraocular pressure (IOP) by applying a force on the globe of the eye and measuring the amount of indentation or intraocular tension by applanation (applying a small, flat disk to the cornea) to aid in the screening of glaucoma.
It identifies the classification and product codes for tonometers and provides information to manufacturers on addressing risks related to these devices in premarket notifications.
The FDA recommends that the submission contain a device description and its intended use, device design requirements, risk analysis methods, device characteristics and a description of the performance aspects.
The guidance also states that a company conducts testing on a set of three or more eyes for each pressure value, with 10 measurements per eye. Each eye should only be used at one pressure. In addition, the FDA suggested that all non-Goldmann-type tonometers be compared with a calibrated Goldmann-type applanation tonometer.
For more information, access the guidance online at http://www.fda.gov/cdrh/ode/guidance/1593.html (http://www.fda.gov/cdrh/ode/guidance/1593.html).