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.
Isaac has authored and submitted numerous FDA 510(k) premarket notifications across a wide range of medical technologies, including medical autoclaves, sterilization wraps, laparoscopic irrigators, self-fitting hearing aids, biomicroscopic instruments, and Software in a Medical Device (SiMD). His experience spans the full regulatory lifecycle—from device classification and risk management to biocompatibility, sterilization validation, and software documentation—utilizing the FDA eSTAR program to streamline submissions. Isaac’s expertise also includes biocompatibility, cybersecurity risk assessment, software validation, quality system compliance, and substantial equivalence justification for both hardware and software-based medical devices. As a medical device regulatory affairs consultant, he applies a strategic, compliance-driven approach to ensure FDA readiness and successful market access.
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.
Can Distributors File a 510(k) for Chinese Medical Devices?
YES! FDA rules (21 CFR 807) let the distributor file as the applicant, securing control over the 510(k) and U.S. market entry. Many foreign manufacturers dodge filings or lack FDA know-how, risking delays and rejections. Filing the 510(k) as a distributor protects your brand and allows your company (regardless of your company size) to control the marketing of the device. This approach can be rewarding, but challenging without their data, specs, testing—but I can handle that. I have 15 years of FDA expertise and product development, I craft eSTAR 510(k) submissions for medical device. Don’t trust manufacturers to prioritize you.
Should I have a Pre-Sub meeting with the FDA?
Mastering the FDA Pre-Sub Meeting: Your Key to Medical Device Regulatory Success
As a medical device regulatory affairs consultant, I’m frequently asked to guide clients through FDA Pre-Submission (Q-Sub) meetings. A Pre-Sub meeting is a vital step to clarify the regulatory pathway for medical devices during development. Whether you’re navigating a 510(k), De Novo or PMA, this process can streamline FDA approval by addressing uncertainties early, especially for innovative devices like drug delivery systems or invasive tools. However, scheduling takes 75–90 days, and preparation demands significant resources, typically $3,000–$15,000 for consulting, drafting, and strategizing. Here I will respond to frequently asked questions.
What is a Pre-Sub meeting? A Pre-Sub is a type of Q-Submission, the FDA’s term for pre-submission interactions where sponsors discuss device classification, testing requirements, product code, or regulatory strategies with the FDA before a formal 510(k), De Novo or PMA submission.
What’s the difference between a Pre-Sub and Q-Sub? There’s no difference; Pre-Sub is a Q-Sub category focused on pre-submission FDA feedback.
Is a Pre-Sub required for a 510(k)? No, Pre-Sub meetings are not required.
Should I pursue a Pre-Sub meeting for my device? Depends. For a device with a clear predicate and identical or similar indications for use statement, a Pre-Sub meeting can lengthen the time to device clearance, rendering the meeting unnecessary and an inefficient use of resources and time. HOWEVER, for novel technologies, like a device adjusting drug doses in real time or a new surgical instrument or a device that is difficult to classifty, a Pre-Sub meeting will help align with FDA expectations. In fact, for complex or novel devices, a Pre-Sub meeting can actually streamline the device review.
How much does the Pre-Sub meeting cost? The FDA charges no fee, but preparation costs vary. Reviewing client drafts takes 20–35 hours; drafting from scratch requires 40–65 hours at, depending on complexity.
How long does it take to schedule? After submission through the eSTAR process, the FDA schedules the meeting within 75–90 days. The meeting itself lasts about 60 minutes, covering your presentation and FDA feedback.
What materials are needed? A cover letter, device description, proposed classification (e.g., Class II or III), proposed product code, specific questions on testing or clinical data, supporting preclinical results are all required for the Pre-Sub documentation. A presentation (i.e. Power Point or video product demonstration) is strongly encouraged.
Is the Pre-Sub meeting held in person or remote? Pre-Sub meetings are typically held remotely via teleconference, but in-person meetings at FDA facilities can be requested, depending on availability and need. I have done both.
What happens after? The FDA provides meeting minutes within 15 days, guiding your 510(k), PMA, or De Novo strategy, potentially reducing approval delays.
Why invest in a Pre-Sub? For complex devices—like those delivering chemotherapy or performing invasive procedures, Pre-Subs clarify requirements, saving costly revisions. I’ve supported 510(k)s for devices heating treatment fluids and PMA reports for ablation technologies, I have leveraged Pre-Sub meeting minutes in device submissions. If your device has an obvious predicate, you might bypass the Pre-Sub process to save time and resources. Pre-Sub meetings are a strategic investment for medical device regulatory success. They offer clarity, reduce risks, and accelerate FDA clearance for complex products with vague and unclear regulatory pathways. They can provide a roadmap to compliance and market entry. Contact me to optimize your Pre-Sub strategy and boost your regulatory journey.