With new medical technologies, when making product development and commercialization decisions, understanding the FDA global regulatory pathway is critical. eZassi developed a US Regulatory Calculator to provide new medical technology developers the potential FDA pathway. With the US Regulatory Calculator, in minutes you receive the likely regulatory FDA classification and product codes for medical devices in Cardiovascular, Orthopedic, Gastroenterology & Urology, General/Plastic Surgery or Radiological technology.
For a more comprehensive regulatory view, use the full version of the e-Zassi InnoVision™ tool where you’ll be able to generate a detailed product analysis that includes both US and EU regulatory classifications.
With this information you will be able to instantly compare both marketplaces, a key component of being able to decide where it’s more favorable to test or launch new products first. The report also generates other pivotal development and commercialization data points such as end-user call pattern, reimbursement, manufacturing and clinical status.
