Before a medical device can be legally marketed in the United States, it must receive clearance or approval from the U.S. Food and Drug Administration (FDA). The two primary regulatory pathways for this are the 510(k) premarket notification and the Premarket Approval (PMA) application.
A 510(k) submission is required for most Class II medical devices and demonstrates that a new device is substantially equivalent to a legally marketed predicate device. It is the most common FDA pathway and is often used for devices with moderate risk and established technology.
A PMA submission, by contrast, is required for Class III devices, which pose the highest risk to patients and users. These submissions demand robust clinical and non-clinical evidence to demonstrate safety and effectiveness and typically involve a longer, more rigorous FDA review process.
Understanding which pathway applies to your device and preparing the correct documentation is critical to achieving U.S. market access. At GLOBAL, we offer end-to-end regulatory support for both submission types, guiding you from early strategy to FDA clearance or approval.
Our Services Include:
FDA Regulatory Strategy for Medical Devices
Our expert team supports every step of your U.S. submission pathway. We help determine the most appropriate route, whether 510(k), De Novo, or PMA, based on your device classification, technological characteristics, and clinical profile.
Our services include:
FDA Submission Services - 510K
We prepare and manage all aspects of your 510(k) submission, including:
FDA Submission Services - PMA Application
Our PMA experts guide your team through this intensive FDA review process, offering:
FDA Submission Services - De Novo Pathway
For novel, low to moderate-risk devices, we offer complete De Novo submission support, including:
Pre-Sub Meetings and FDA Interactions
We ensure your FDA communications are strategic and effective:
FDA Response and Remediation Services
If you’ve received a Refuse to Accept (RTA) or Additional Information (AI) request, we provide:
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Your Partner in FDA Submissions
Quality work, efficient collaboration, timely submissions
With a team of experienced regulatory writers and former reviewers, we provide regulatory writing for devices that meets Notified Body expectations the first time. Whether you need help writing a 510(k) or managing an entire technical documentation package, GLOBAL delivers.
Why Choose GLOBAL for FDA Submissions?
By partnering with GLOBAL, you can choose how best to utilize our expertise.
Frequently Asked Questions About FDA Submissions
What is a 510(k)?
A 510(k) is a premarket notification to the FDA demonstrating that your device is substantially equivalent to a legally marketed predicate device. It is the most common route to market for Class II medical devices.
What is a PMA application?
A Premarket Approval (PMA) is the most stringent FDA submission pathway, required for Class III medical devices. It requires extensive clinical and non-clinical data demonstrating safety and effectiveness.
How do I know if I need a 510(k), De Novo, or PMA?
The appropriate pathway depends on your device’s risk level, technological novelty, and availability of a predicate. We offer regulatory pathway assessments to help you select the optimal route.
What causes the FDA to reject a 510(k) submission?
Common reasons include:
We help mitigate these risks with comprehensive document preparation and RTA/AI remediation services.
What are typical timelines for FDA clearance or approval?
Our team helps reduce delays by ensuring submission readiness and review alignment.
Can you help with FDA Pre-Submissions?
Yes. We assist with Pre-Submission planning, briefing package development, and meeting preparation. This step is critical for clarifying expectations and minimizing surprises during formal review.
Do you offer eCopy formatting and submission?
Absolutely. We compile and validate eCopy submissions in full compliance with FDA’s technical standards, ensuring smooth upload to the FDA’s Electronic Submissions Gateway (ESG).
Contact us today!
Bring your medical device to the U.S. market with confidence. Whether you need full FDA 510(k) submission support, PMA documentation, or De Novo pathway guidance, GLOBAL has the expertise to help you succeed.