FDA official shares 11 steps of bringing products to market

Ophthalmologists should remember 11 steps when attempting to bring products tothe market, said Malvina Eydelman, MD, director, division of ophthalmic and ENT devices, Centerfor Devices and Radiological Health, FDA, in a mini-symposium on glaucoma public policy duringthe American Glaucoma Society annual meeting. Dr. Eydelman provided the perspective of theregulator.The 11 steps:

• Determine whether the product is a medical device, drug, biologic, or a combination product.
• Determine the device classification (Class I, Class II, or Class III) at http://www.fda.gov/cdrh/devadvice/3131.html.
• Check to see whether FDA guidance, which represents the agency's current thinking on thematter, exists at http://www.fda.gov/cdrh/guidance.html. FDA guidance is not binding, Dr.Eydelman said.
• Check to see whether recognized standards exist.
• Design an appropriate clinical trial. "Taking time to plan and think is the biggestrecommendation," she said.
• Determine the location of the clinical trial.
• Select qualified investigators appropriate for the particular product.
• Provide adequate training to those who will be involved with the study, stressing theimportance of the informed consent process.
• Optimize the dataset.
• Ensure adequate monitoring.
• Ensure investigator compliance.