regulatory guidance:

drug development& medical devices

the Development of new Medicines & medical devices around the globe is highly regulated by a wide variety of Governmental agencies & institutions. three major authorities set the tone: Food Drug Administration, European Medicine Agency and Japanese authority regulating medicines & devices.

the toxicological pathologist plays an important role in this Regulatory process.

 
 

ophthalmic medical devices

FDA & Center for devices and radiologic health (cDHR)

There are various examples of Ophthalmic devices which need to follow a strict FDA approval path.

  1. therapeutic: contact lenses & products

  2. Prosthetic: keratoprosthesis, IOL, Aqueous shunts

  3. Diagnostic: camera, tonometers, OCT devices

  4. surgical: IOL, IO-gas, phacophragmentation systems