Comprehensive Expertise For Any Phase Of The FDA Process
Isaac A Erickson, MBS, President of IMDS Consulting, has over 15 years experience combining technical proficiency with in-depth regulatory knowledge to drive innovation in a global landscape.
- eSTAR 510(k) submissions
- Regulatory strategy
- Medical device labeling
- UDI implementation
- EU MDR
- Clinical evaluation
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WHY ISAAC?
A True Expert in Medical Device Regulatory Strategy & Compliance
At the intersection of regulatory strategy and device innovation, Isaac Erickson brings unmatched expertise in medical devices, automation, and life science instrumentation to help companies navigate the complex regulatory FDA approval process with confidence. With a proven track record of guiding products from concept to market, Isaac specializes in strategic regulatory planning that ensures FDA and EU MDR compliance, so the client can focus on marketability and competitive advantage. Isaac’s deep understanding of product design, software development, cybersecurity, and the 510(k) and EU MDR submission processes allows him to streamline product clearance and approvals, minimize delays, and position products for long-term success. His insights can help de-risk development, accelerate FDA clearances, and optimize your go-to-market strategy, ensuring your innovation reaches patients with full regulatory confidence.
TESTIMONIALS
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FREQUENTLY ASKED QUESTIONS
You Have Questions, We Have Answers
What is the difference between a 510(k), De Novo, and PMA submission?
When you’re bringing a new medical device to market, there are a few regulatory pathways to consider. First, there’s the 510(k) submission, which is the most common route. You’d use this if your device is pretty similar to something that’s already FDA-approved—what they call a ‘predicate’ device.
If there’s nothing out there quite like your device, but it’s still low to moderate risk, you’d go with a De Novo classification request. That’s for newer technologies that don’t quite fit into existing categories but don’t need the most intense review either.
Then there’s Premarket Approval (PMA)—this one’s the most thorough (and toughest). It’s for high-risk, Class III devices, and you’ll need solid clinical trial data to show that your device is both safe and effective.
How do I determine my medical device’s classification?
The FDA classifies devices into three categories based on risk:
- Class I – Low risk, subject to general controls (e.g., bandages, toothbrushes). Most do not require premarket submission, but often require registration and will open the manufacturer to FDA audits.
- Class II – Moderate risk, typically requires a 510(k) submission (e.g., infusion pumps, powered wheelchairs), followed by routine FDA audits
- Class III – High risk, requiring PMA submission with clinical data (e.g., pacemakers, artificial heart valves), followed by routine FDA audits.
Search the FDA Product Classification Database or consult 21 CFR Parts 862-892 to determine classification.
What testing and documentation are required for FDA submission?
FDA submissions require:
- Predicate Decision – Comparison of the subject device and predicate device required for 510(k) submissions
- Safety & Efficacy Testing – Includes biocompatibility, electrical safety, and software validation if applicable.
- Risk Assessment – Conducted under ISO 14971 to ensure hazards are mitigated.
- Clinical Data – Required for Class III (PMA) and sometimes Class II devices.
- Labeling & Instructions for Use – Must comply with FDA labeling regulations.
- Quality System Compliance – The device must be manufactured under 21 CFR Part 820 (Quality System Regulation, QSR).
How long does the FDA approval process take?
The timeline for FDA review varies depending on the type of submission:
510(k) Review typically takes between 90 and 180 days, although it can take longer if the FDA requests additional data.
De Novo Review generally requires 6 to 12 months or longer, as it involves a more in-depth classification process.
PMA Approval often takes 12 to 24 months, factoring in the time needed for clinical trials and FDA inspections.
Breakthrough Device Designation is designed to expedite the review process for innovative technologies that address serious or life-threatening conditions.
What post-market requirements apply after FDA approval?
Adverse Event Reporting – It’s essential to comply with Medical Device Reporting requirements outlined in 21 CFR Part 803. Any adverse events involving your device must be reported promptly and accurately.
Corrective and Preventive Actions (CAPA) – Any identified defects or safety concerns must be thoroughly investigated, reported, and addressed through a documented CAPA process to ensure ongoing product safety and compliance.
Annual Reports and Inspections – Devices approved under a Premarket Approval (PMA) are required to submit annual reports and remain prepared for routine FDA inspections to maintain regulatory compliance.
UDI Compliance – All applicable devices must be labeled with a Unique Device Identifier (UDI) to support traceability, facilitate recalls, and enhance post-market surveillance.