FDA 510(K) and PMA Submission Support
Expert Strategy, Authoring, and End-to-End Regulatory Services
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:
- Regulatory pathway assessment and planning
- Predicate device identification and classification
- Labeling and IFU strategy
- FDA pre-submission meeting preparation
- Review and integration of RTA and AI feedback
FDA Submission Services - 510K
We prepare and manage all aspects of your 510(k) submission, including:
- Predicate device comparison and substantial equivalence rationale
- Device description and technology summary
- Performance testing documentation
- Clinical data summaries
- Labeling, sterilization, and shelf-life documentation
- Complete authoring of all required 510(k) sections
- Review and response to RTA and AI letters
FDA Submission Services - PMA Application
Our PMA experts guide your team through this intensive FDA review process, offering:
- Regulatory and evidence strategy development
- PMA module planning and documentation
- Integration of clinical trial data and non-clinical testing
- Labeling and benefit-risk evaluations
- Advisory panel preparation, if required
- Final submission formatting and eCopy compliance
FDA Submission Services - De Novo Pathway
For novel, low to moderate-risk devices, we offer complete De Novo submission support, including:
- Risk classification and evidence planning
- Clinical and non-clinical justification
- Documentation aligned with special controls
- Full De Novo submission writing and formatting
Pre-Sub Meetings and FDA Interactions
We ensure your FDA communications are strategic and effective:
- Pre-Submission (Q-Sub) planning and questions
- Briefing package development
- Meeting preparation and simulation
- Response planning and documentation
FDA Response and Remediation Services
If you’ve received a Refuse to Accept (RTA) or Additional Information (AI) request, we provide:
- Gap analysis and remediation roadmap
- Technical and clinical data updates
- Complete response authoring and formatting
Read more at our blog!
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.
- Proven success with Class II and Class III medical devices
- In-depth knowledge of FDA formatting and submission expectations
- U.S.-based regulatory writing and strategy team
- Streamlined project management and transparent communication
- Trusted by startups and multinational medical device companies
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:
- Inadequate predicate justification
- Missing performance or biocompatibility data
- Labeling deficiencies
- Poor formatting or incomplete sections
We help mitigate these risks with comprehensive document preparation and RTA/AI remediation services.
What are typical timelines for FDA clearance or approval?
- 510(k): Approximately 90 calendar days, excluding review cycles
- PMA: 180 or more days, depending on complexity and advisory panel involvement
- De Novo: Typically 120 to 150 days
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.
