March 14, 2014 8:00 a.m. to 6:00 p.m.: Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
March 14, 2014 8:00 a.m. to 6:00 p.m.: Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Hilton Washington, DC/North
620 Perry Pkwy.
Gaithersburg, MD 20877
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
You can access the current roster of the Ophthalmic Devices Panel HERE.
During this meeting, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company. “Visian TICL proposed indications for use:
• For adults 21-45 years of age;
• For correction of myopic astigmatism in adults with spherical equivalent ranging from 3.0D to ≤ 15.0D with cylinder of 1.0D to 4.0D;
• For the reduction of myopic astigmatism in adults with spherical equivalent ranging from greater than 15.0D to 20.0D with cylinder 1.0D to 4.0D;
• With an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 Diopter for 1 year prior to implantation); and
• The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.”
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Do you want to find out what happens during this device’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a summary of this meeting’s outcome!
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us