Since the firm’s inception, the experts on Greenleaf’s Medical Devices and Combination Products team have been assisting clients with all aspects of the regulatory review process for medical devices and combination products, such as:
- Determining product designation and classification;
- Evaluating regulatory options for device modifications;
- Developing and implementing Pre-Submission strategy;
- Identifying predicate device(s);
- Addressing performance data and labeling requirements;
- Demonstrating substantial equivalence/safety and effectiveness;
- Preparing device companies for meetings and calls with FDA; and
- Responding to the Agency’s requests for additional information.
- Request for Classification Information (513(g));
- Premarket Notifications (510(k)s);
- Premarket Approval Applications (“PMAs”);
- Petitions for Evaluation of Automatic Class III Designation (de novo);
- Humanitarian Use Designation (“HUD”) / Humanitarian Device Exemption (“HDE”) applications; and
- Investigational Device Exemption (“IDE”) applications.
Greenleaf’s Devices Team focuses on a collaborative approach to problem solving within our team, with our Greenleaf Drugs and Compliance colleagues, with other consulting experts, and most importantly, with our clients.
Please contact Catherine Rowe for additional information about any of the above services and to arrange an introductory meeting.