FDA 510(k) and PMA Submission Support
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.
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.
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
Milestones from the Past 18 Months
Our FDA Submission Services Include:
510(k) Submission Support
- Predicate device comparison and substantial equivalence rationale
- Device description and technology summary
- Performance testing (bench, biocompatibility, electrical safety) documentation
- Clinical data summaries, if applicable
- Labeling, sterilization, and shelf-life documentation
- Complete authoring of all required 510(k) sections
- Review and response to RTA and AI letters
PMA Application Support
- 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
De Novo Pathway Support
- 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
- Pre-Submission (Q-Sub) planning and questions
- Briefing package development
- Meeting preparation and simulation
- Response planning and documentation
FDA Response and Remediation Services
- Gap analysis and remediation roadmap
- Technical and clinical data updates
- Complete response authoring and formatting
Why Choose GLOBAL for FDA Submissions?
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
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.
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.
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.
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.
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.
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.
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).