FDA 510k Clearance | Medical Device Regulatory Strategy

Medical device getting tested for fda approval

“Finding the right partner means choosing someone who knows where the FDA is most likely to raise questions and has a strategy for addressing them before they slow you down. Drawing on deep regulatory intelligence and a wealth of hands-on experience, we’ve navigated many challenging submissions, and we’re ready to put that experience to work for you.”

–Niki Spaniel, Senior Regulatory Consultant

CMD MedTech provides comprehensive regulatory submissions for medical devices, guiding companies through the FDA medical device approval process from initial regulatory strategies through successful market authorization. Our experienced team helps you navigate 510k clearance, PMA approval, and De Novo pathways while avoiding costly delays and ensuring your submission meets FDA expectations.

Why Choose CMD MedTech for 510k Clearance and Medical Device Submissions

Extensive experience with FDA 510k clearance, PMA approval, De Novo pathways, and Investigational Device Exemption (IDE) submissions across diverse device types and therapeutic areas
Deep regulatory intelligence and understanding of current FDA thinking, expectations and hot-button issues
Strategic approach to regulatory pathway selection based on device classification and predicate analysis
Proven ability to anticipate FDA questions and position regulatory submissions for medical devices for efficient review
Experience managing complex FDA interactions, including pre-submissions, clarification meetings, and response strategies
Knowledge of annual small business determination processes to minimize FDA fees
Experience with Breakthrough Designation Requests and Pathways

Benefits of CMD’s Regulatory Expertise

Reduce submission timeline through proper planning, complete documentation, and strategic FDA interactions
Minimize regulatory risk by identifying potential issues early and positioning submissions effectively
Optimize FDA fees through small business determination guidance and strategic submission timing
Navigate complex pathways with confidence, whether 510k clearance, De Novo process, PMA approval, or alternative routes
Handle FDA questions efficiently with experienced response strategies that address reviewer concerns
Make informed decisions about risk tolerance and submission strategies based on regulatory intelligence and your business model

“Our productive conversations with FDA reflect the depth of our expertise and the thorough preparation that goes into each submission or interaction. We can facilitate these dialogues and submissions, tailoring them to your unique product and pathway.”

–Micki Conklin, Senior Regulatory Specialist

Pricing for Our Services

Our regulatory submission services are customized based on your pathway complexity, device classification, and submission requirements. We provide transparent pricing for both regulatory strategy development and full submission management. Contact us to discuss your specific regulatory needs and receive a detailed proposal.

5-Step Process for Regulatory Success

Determine the appropriate FDA regulatory pathway by analyzing device classification, identifying suitable predicates, and assessing regulatory requirements.

Develop and submit pre-submission packages to the FDA for pathway confirmation and early feedback on critical submission elements.

Assemble a comprehensive submission package, including device descriptions, your 510k summary, predicate comparisons, V&V testing data, Clinical data, and every required element to support a smooth and successful regulatory pathway.

Manage the submission review process, respond to FDA interactive questions, additional information requests, and coordinate clarification meetings as needed to address reviewer concerns.

Guide you through final clearance or approval requirements and support establishment registration of your company as well as post-market compliance processes.

Regulatory Pathways We Support

Exempt Pathway

Typically applies to Class I (low-risk) and some Class II medical devices with well-established safety and effectiveness profiles. While exempt from FDA premarket notification, these devices are still subject to other FDA requirements.

510k Clearance

The most common pathway for Class II medical devices, demonstrating substantial equivalence to existing predicate devices through comprehensive documentation and testing data.

PMA Approval

Required for Class III high-risk devices, providing reasonable assurance of safety and effectiveness through extensive clinical evidence and manufacturing documentation.

De Novo Classification

For novel low-risk devices without suitable predicates, establishing new device classifications through risk-based evaluation processes.

IDE Submissions

Investigational Device Exemption (IDE) applications for significant risk clinical studies, including protocol development and ongoing study management and FDA reporting.

Additional Services We Offer

Comprehensive Regulatory Support

Our medical device regulatory services encompass all aspects of FDA compliance beyond submissions, including regulatory strategy and ongoing guidance.

Quality System Integration

We help ensure your quality management system supports regulatory submission requirements and ongoing compliance obligations.

Software Documentation Support

For devices with software components, we coordinate with our software development experts to ensure proper regulatory documentation and compliance.

Clinical Strategy

We guide you in determining the clinical evidence requirements for your premarket submission, leveraging literature reviews or supporting the design of clinical investigations, as needed.

Post-Market Compliance

We provide guidance on annual reporting requirements, change control processes, and ongoing FDA compliance obligations after market authorization.

Frequently Asked Questions About Regulatory Submissions for Medical Devices

When should I start my regulatory strategy?

Begin as soon as you have a strong device concept. An early medical device regulatory strategy helps identify potential predicates, informs design decisions, and ensures that your development approach aligns with FDA requirements from the beginning. CMD helps you develop the right strategy early to avoid expensive and time-consuming redesigns later.

Should I submit a pre-submission to FDA?

For most devices with any pathway uncertainty, yes. Pre-submissions provide valuable FDA feedback on predicate selection, testing requirements, human factors or clinical study design, and submission approach, helping prevent delays during formal review. CMD guides you through effective pre-submission strategies that maximize FDA feedback value.

How long does the FDA review process take?

Timeline varies by pathway and submission quality. Well-prepared 510k submissions typically review within 3-6 months, while PMA approvals can take significantly longer. Proper preparation and complete documentation are key to efficient review. CMD ensures your submissions are complete and well-positioned for faster FDA review.

What happens if FDA sends questions about my submission?

This is common and manageable. We help analyze FDA questions, develop comprehensive responses, and may recommend clarification meetings to address complex issues. Our experience helps distinguish between minor clarifications and more significant concerns–we help you navigate every step of the process with confidence.

How much do FDA submissions cost?

Annually set fees for the FDA medical device approval process vary by pathway and company size. For qualified small businesses, 510k fees are approximately $6,000 versus $24,000 for standard applicants. We help determine eligibility and optimize fee structures for your submissions.

Regulatory Clearance & Approval: FDA 510k Clearance