FDA
14th April 2014

Meeting Announcement – Contact Lenses and Accessories

May 13, 2014 8:00 a.m. to 6:00 p.m.:  Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement.

Meeting Announcement – Contact Lenses and Accessories

May 13, 2014 8:00 a.m. to 6:00 p.m.:  Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Where:

Holiday Inn Express/Highlands Conference Center
Oak I and II Conference Rooms
20260 Goldenrod Lane
Germantown, MD 20876
301-605-1434

 

At this meeting, the Ophthalmic Devices Panel of the Medical Devices Advisory Committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories. The discussion will include topics such as microbiological and chemical pre-clinical testing, revision of pre-clinical test requirements to address patient non-compliance, modification of rigid gas permeable lens care regimens, and labeling for these devices.

The current guidance for contact lenses entitled “Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses” and can be found here.

The current guidance for contact lens accessories entitled “Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products” and can be found here.

Please click here for the current roster of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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