Mobile Health Care FDA and Regulatory Issues

Understanding the regulatory guidelines concerning mobile devices and applications is an essential component of early-stage product development. Our FDA and regulatory attorneys help clients in the development phases by counseling on when regulatory approval is necessary and where regulatory issues may be minimized.

Our FDA Regulatory attorneys provide the following services: 

  • Counsel on product development within current and evolving regulatory guidelines 
  • Application submission and negotiation 
  • Product testing and clinical trials and investigational device exemptions 
  • Sales, marketing, and promotion of FDA products 
  • Compliance and enforcement with the FDA, DEA, and CMS