FDA 510K Regulatory Consulting Services
Navigate the FDA 510K submission process with confidence. Expert regulatory consulting to ensure your medical device gets to market faster.
What is FDA 510K Premarket Notification?
FDA 510K is a premarket submission made to FDA to demonstrate that a medical device is at least as safe and effective (substantially equivalent) to a legally marketed predicate device. The 510K process is the most common pathway for medical device clearance in the United States.
Successfully navigating the 510K process requires deep regulatory knowledge, meticulous documentation, and strategic presentation of clinical and technical data. Our expert team has a 100% success rate helping medical device companies achieve FDA clearance.
Comprehensive FDA 510K Services
End-to-end regulatory support from strategy to submission and FDA interactions
Regulatory Strategy
Comprehensive regulatory strategy development including classification determination, predicate device selection, and regulatory pathway assessment.
- Device classification
- Predicate selection
- Pathway assessment
510K Submission Preparation
Complete preparation of 510K submission including all required sections, technical documentation, and supporting materials.
- Cover letter & forms
- Device description
- Substantial equivalence
Performance Testing
Design and oversight of performance testing protocols to demonstrate safety and effectiveness of your device.
- Test protocol development
- Bench testing
- Biocompatibility
Risk Analysis
Comprehensive risk analysis and management documentation following ISO 14971 standards and FDA guidance.
- Risk assessment
- Risk mitigation
- Risk management report
Clinical Evaluation
Clinical data assessment and clinical evaluation reports to support substantial equivalence claims.
- Literature review
- Clinical study design
- Clinical evaluation report
FDA Correspondence
Expert handling of FDA questions, additional information requests, and all post-submission correspondence.
- Response to FDA questions
- Additional information
- FDA meetings
Our 510K Submission Process
A systematic, proven approach to FDA clearance
Initial Assessment
Comprehensive evaluation of your device, regulatory requirements, and optimal submission strategy.
Gap Analysis
Identify gaps in current documentation and testing, create detailed plan to address all FDA requirements.
Testing & Documentation
Oversee performance testing and compile all technical documentation required for submission.
Submission Preparation
Prepare complete 510K submission package with all required sections formatted per FDA guidelines.
Quality Review
Thorough internal review to ensure completeness, accuracy, and compliance before submission.
Submission & Follow-up
Submit to FDA and manage all post-submission correspondence until clearance is achieved.
Device Categories We Serve
Experience across a wide range of medical device categories
Why Choose Our 510K Services
100% Success Rate
Perfect track record of FDA clearances with no rejections or major deficiencies in the past 3 years.
Regulatory Experts
Team of former FDA reviewers and experienced regulatory affairs professionals with decades of combined experience.
Fast Clearance
Average clearance time of 90 days, faster than the FDA standard review time through proper preparation.
Comprehensive Service
End-to-end support from initial strategy through FDA clearance and post-market compliance.
Transparent Pricing
Clear, upfront pricing with no hidden fees. Fixed-fee options available for standard submissions.
Ongoing Support
Post-clearance support for labeling, quality systems, and ongoing regulatory compliance.
Ready to Get FDA Clearance?
Schedule a free regulatory strategy consultation to discuss your device and 510K pathway.
Schedule Free Consultation510K FAQs
How long does the 510K process take?
The FDA review process typically takes 90 days, though it can be longer if additional information is requested. Preparation time varies based on device complexity but typically ranges from 3-6 months. Our average total time from engagement to clearance is 6-9 months.
What is the cost of 510K consulting services?
Costs vary based on device complexity, testing requirements, and submission type (Traditional, Special, or Abbreviated). We provide detailed quotes after an initial assessment. Typical projects range from $50,000 to $150,000 including all consulting services.
Do you handle clinical studies for 510K?
Yes, we design and oversee clinical studies when needed to support 510K submissions. However, many devices can be cleared based on bench testing and substantial equivalence without clinical data.
What if my 510K is rejected?
With our thorough preparation process, rejections are extremely rare. If additional information is requested, we respond promptly and comprehensively. We stand behind our work and provide ongoing support until clearance is achieved.