Regulatory

Regulatory Services

 

We have extensive experience in the design and administration of regulatory projects for the FDA approval of ophthalmic devices, and have been very successful in achieving timely and broad approvals for new devices. Our values-driven approach to FDA Studies is the main reason for our success:

 

  • We respect the process and believe that honest, thorough validation of devices serves the best interests of both patient safety and the commercial success of the manufacturer.
  • We respect the professionals at FDA. As such, we have worked on FDA committees, advised ANSI committees and published peer-review articles with co-authors from the FDA. We enlist their support and guidance as we negotiate the process.
  • We look beyond approval in the design of our studies, in order to position products for commercial success after the studies are complete.
  • We have more work than we can accept, which aligns our interests with the client’s. Our goal is to complete projects as efficiently as possible so we can move on to the next one.

 

In the CRS LASIK Studies, we achieved the first FDA approvals for LASIK. This unusual project was physician sponsored, and to our knowledge is the only time that one company gained approval recommendations for competing products in the same meeting of the Ophthalmic Devices panel, in 1999.

 

Subsequently, we teamed up with O’Connell Regulatory Consultants to conduct a series of FDA projects for the WaveLight Excimer Laser system (now owned by Alcon, Inc.) from 1999 to 2008. To the best of our knowledge, these approvals (listed below) comprise the fastest, cheapest and broadest series of approvals ever obtained for excimer lasers.

 

We have also served as a regulatory consultant to Envoy Medical (Implantable Hearing Aid Device). FDA approval received 2011.

 

SurgiVision® Consultants, Inc. has administered and/or conducted the United States FDA Clinical Trials for several excimer laser platforms. Multiple PMA / PMA supplements have been approved under our administration. Below is a partial listing of our regulatory approvals. Some activities are not listed for reasons of confidentiality: