US FDA Consulting for Medical Devices and IVDs

FDA 510(k) Clearance Consulting

The US accounts for more than 40% of the global medical device market. While many device manufacturers are intimidated by the process of gaining 510(k) clearance for their medical device, the FDA provides a wealth of information on the requirements, and is generally accessible and helpful. Still, the sheer abundance of relevant FDA guidance documents can be overwhelming  and requirements often get missed or misinterpreted. NAMSA’s regulatory team has deep experience preparing the data needed to support your 510(k) application and can assist with every step along the way.

FDA De Novo Submission Support

Unlike many other markets, the US FDA classification process for medical devices and IVDs is based on a “predicate” system. This means that any new applications for devices must prove that they have the same intended use and indications for use as another similar device already cleared by the FDA. What happens if you have invented a novel new technology? One option is to pursue the De Novo classification pathway. As a leading medical device CRO, NAMSA can help you gather the data needed and prepare the application required to gain De Novo classification.

FDA Investigational Device Exemptions

If a device maker is developing a new product or pursuing a new indication for an existing device and has determined that a clinical investigation is required; the first consideration is whether the proposed investigation is a ‘significant’ or ‘non-significant’ risk to the patients.If a device presents significant risk, both IRB approval and an FDA Investigational Device Exemption (IDE) is required.

NAMSA can support companies wishing to submit an IDE with the following processes:

• Helping with the determination of significant vs. non-significant risk
• Assisting with the pre-submission meeting to discuss risk determination, clinical study outline, and other test requirements
• Compilation of IDE documents
• Facilitation and management of required clinical studies
• 510(k), De Novo and PMA Submissions

FDA Premarket Approval Consulting

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 preclinical 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.

FDA Pre-Submission Consulting

NAMSA is the industry leader in driving successful Pre-Submission meetings with the US FDA. Leveraging our team’s experience and strong working relationships with regulators, clients consistently place trust in NAMSA to accelerate clearance and approvals of innovative technologies. Not only do we understand how to obtain the most meaningful feedback possible throughout the Pre-Sub process, but we also possess unmatched experience on how to utilize pre-submissions to accelerate product approvals.

NAMSA’s team of medical device regulatory consultants puts their expertise to work for you. We have been involved in over 500 Q-Submission/Pre-Submission meetings for 510(k)s, De Novos, and PMAs. Our weekly interactions with the agency keep us up to date with agency expectations and help mitigate project risk. Our consultants pose the correct questions to the FDA and focus on accelerating the approval process for your device.