US FDA Premarket Approval (PMA) Consulting for Class III Medical Devices

High-risk Class III medical devices sold in the US must obtain regulatory approval through the FDA Premarket Approval pathway. Your PMA application will include a substantial amount of data from preclinial research and clinical study data and must demonstrate to the FDA that your device is safe and effective. This process takes years to complete but NAMSA can help you shorten your path to market, improve your chance of success and reduce overall costs. Learn how.

Quick facts about US FDA PMA process: 

• The FDA only approves 20-40 new Class III medical device PMA submissions each year.
• The PMA application is the summation of extensive preclinical and clinical research.
• FDA conducts an initial scientific review and will let you know if the application is accepted within 45 days.
• PMA decisions are made by FDA within 180 days.
• A facility inspection will be conducted by FDA prior to PMA approval.
• PMAs do not expire as long as no changes are made to design, intended use, indications for use, etc.

Let NAMSA Prepare Your PMA and Guide You Through the FDA and IRB Process

The NAMSA testing, clinical and consulting teams have extensive experience with FDA regulatory submissions for high risk devices. As one of the largest medical device CROs, we have helped manufacturers conduct preclinical research, execute clinical trials and prepare FDA submissions for some of the most complex medical technology available today, including implants. We can assist with traditional and modular FDA Class III PMA submissions, including the following:

• Help you obtain Investigational Device Exemption (IDE) approval from an Institutional Review Board (IRB) prior to clinical trials and preclinical lab studies.
• Lead the “determination” meeting with FDA to get feedback on the scientific evidence (clinical data) that will be needed to support your Class III application.
• Work with you, the FDA and our in-house clinical trial team to negotiate and design your clinical trial protocol and investigational plan.
• Prepare the final PMA application and lead FDA Q-Submission meetings to obtain pre- and post-submission feedback.
• Implement a QMS in compliance with 21 CFR Part 820 or conduct an FDA mock audit to identify gaps prior to the required FDA inspection of your manufacturing facility.

Shorten the Time to Market for Your Class III Device

NAMSA is 100% focused on medical devices and offers a full spectrum of biological safety testing, clinical research and regulatory compliance services in-house. We can help you develop a comprehensive plan (including costs) for all testing, clinical studies and other compliance activities that will be required to secure FDA Premarket Approval for your medical device. This integrated solution improves your chances of success. Rather than work with separate testing, clinical and regulatory consulting firms, shorten your time to approval with NAMSA. Our APEX PROGRAM is purpose-built for this exact purpose.