Arent Fox handles a wide variety of matters involving FDA regulation of medical devices, including product development and regulatory compliance counseling. We assist clients in product development, including coordinating with investigators, institutions and contract research organizations, drafting research and license agreements, representing companies before the FDA, and appearing before advisory committees. Recent product development-related activities include:
- Securing FDA clearance of numerous pre-market notifications, including wound dressings and dental devices
- Advising clients on a variety of products and providing assurance that FDA pre-market notification was not necessary, including telemedicine products and numerous dental devices
- Preparing agreements with institutions and investigators for the development of cardiac and dental products
In regulatory counseling, we advise clients on regulatory issues involving marketed and investigational medical devices. We counsel clients on proposed advertising, labeling, and promotional materials, including websites. Recent regulatory-related activities include:
- Drafting and submitting comments on proposed regulations involving dental devices
- Conducting a nationwide audit of a major device distributor, including on-site audits of eight facilities and document audits of 20 other locations
- Appearing before the FDA on the possible reclassification of a dental device product
