MedTech Regulatory Submissions Made Easy

Rook Quality Systems

/@RookQualitySystems

Published: March 30, 2025

Open in YouTube
Insights

This webinar, hosted by Rook Quality Systems and QuickVault by Veeva, provides a detailed guide to navigating five common regulatory submissions for medical devices: FDA 510(k), De Novo classification, PMA, CE Mark (EU MDR), and FDA pre-submission (Q-Submission). The presentation emphasizes strategic planning, thorough documentation, and leveraging digital tools to streamline the process for timely market entry. Speakers Jeff Hau and Axel Strombergsson from QuickVault, and Kyle Rose from Rook Quality Systems, combine regulatory consulting expertise with a demonstration of how an electronic Quality Management System (eQMS) can centralize and manage the complex documentation required for these submissions.

The first major segment focuses on the FDA 510(k) pathway, the most common route for Class II devices. Key components of a 510(k) submission are detailed, including administrative information (like the crucial small business designation to reduce fees from ~$24,000 to ~$6,000), device description, predicate device comparison, performance testing (bench, animal, clinical, biocompatibility), software documentation, and labeling. A critical insight shared is the realistic timeline: while the FDA states a 90-day review, the actual process often takes 6 to 9 months due to the high probability of an Additional Information (AI) request, which opens a six-month window for response. The discussion then transitions to the De Novo classification for novel, low-to-moderate risk devices without a predicate, highlighting the importance of a risk-benefit analysis and proposed special controls. This is followed by an overview of the highest risk pathway, the Premarket Approval (PMA) for Class III devices, which requires extensive non-clinical and clinical data, and often includes FDA audits of the manufacturing facility and quality system prior to approval.

A significant portion of the webinar is dedicated to the FDA pre-submission (Q-Submission) process, which is strongly recommended for novel devices (De Novo, PMA) and complex 510(k)s. The pre-submission is a free, written request for early feedback from the FDA on the device, intended use, and planned testing (pre-clinical or clinical). The goal is to de-risk the regulatory strategy, clarify the pathway, and ultimately shorten the total review time of the final submission. The speakers advise submitting the pre-submission after a good understanding of the device design is achieved but before formal development and expensive testing begins, aligning with the FDA's guidance that feedback is most effective when requested prior to the execution of planned testing. Finally, the EU CE Mark under the Medical Device Regulation (MDR) is covered, noting the need for an EU Representative, ISO 13485 compliance, a Technical File, and a Clinical Evaluation Report (CER), with review conducted by a contracted Notified Body.

The presentation culminates in a live demonstration of QuickVault's new regulatory submissions functionality. This module is designed to help companies organize and track all submission content—including documents, design controls, and risk management files already stored in the eQMS—in a single, centralized system. The tool provides out-of-the-box templates for eSTAR submissions (FDA) and CE Mark technical files, allowing users to link directly to approved documents within QuickVault, ensuring version control and traceability. Furthermore, the system manages post-submission interactions, such as tracking and preparing responses to FDA Additional Information (AI) requests, streamlining the often-complex back-and-forth with regulatory authorities and minimizing errors associated with managing submissions via shared drives or local laptops.

Detailed Key Takeaways

  • Realistic 510(k) Timelines: While the FDA aims for a 90-day review, companies should budget 6 to 9 months for the 510(k) process. This extended timeline accounts for the high likelihood of an Additional Information (AI) request, which grants the company up to 180 days (six months) to respond.
  • Strategic Use of Small Business Designation: Companies with less than $200 million in annual revenue should apply for the FDA's small business designation well in advance. This designation significantly reduces the 510(k) fee from approximately $24,000 to about $6,000 (2025 rates).
  • Pre-Submission Timing is Critical: The FDA pre-submission (Q-Submission) should be initiated after the device concept and intended use are well-defined, but before commencing expensive formal development and pre-clinical/clinical testing. This ensures FDA feedback guides the testing plan, preventing costly rework.
  • Avoid Open-Ended Regulatory Questions: When submitting a pre-submission, do not ask the FDA "What class is my device?" or "What testing should I do?" Instead, propose a specific classification, predicate, and testing plan, asking the FDA to agree or disagree. This strategic approach maintains control and prevents the FDA from mandating overly burdensome studies.
  • Software Documentation Must Start Early: For software-as-a-medical-device (SaMD), extensive documentation generated throughout the development process (design controls, risk management, validation) is required for the 510(k) submission. Companies must implement a quality system early to track and document software development rigorously.
  • Denovo as a Competitive Advantage: Pursuing the De Novo pathway for novel Class II devices allows the initial applicant to set the special controls (required testing and documentation) for that new product code. This can create a significant competitive barrier for future entrants by establishing high testing standards.
  • Parallel US and EU Strategy: To achieve simultaneous market entry, submit the FDA 510(k) first. During the 6-9 month FDA review period, schedule the ISO 13485 audit and begin the Technical File review with the chosen Notified Body for the CE Mark.
  • PMA Requires Quality System Audits: For Class III PMA submissions, the FDA will conduct audits of the manufacturing facility and the entire quality system (eQMS, design controls, risk management) prior to or during the review process, necessitating a fully mature and compliant QMS.
  • QuickVault Centralizes Submission Prep: Tools like QuickVault eliminate the risks and inefficiencies of managing submissions via spreadsheets or shared drives by centralizing all required documentation (design controls, testing reports, quality events) and linking them directly to the submission structure, ensuring correct version control.
  • Clinical Data is Not Always Required for 510(k): The majority of 510(k) clearances are granted based on pre-clinical (bench and animal) data alone, especially if the device is not a monitoring device or diagnostic. The FDA prefers pre-clinical data if it can adequately demonstrate safety and effectiveness.

Tools/Resources Mentioned

  • QuickVault by Veeva: An eQMS and cross-functional platform specifically for small to medium-sized medical device companies. It supports document control, training, quality events (CAPA, non-conformance), supplier management, design control, risk management, and features a new module for regulatory submission preparation and tracking.
  • Rook Quality Systems: A consulting company specializing in quality and regulatory consulting for medical device companies, assisting with submission preparation (510(k), De Novo, PMA, CE Mark).
  • FDA eSTAR Program: The electronic submission template program mandated by the FDA for 510(k) submissions, designed to streamline the submission and review process.
  • Med Innovator: An incubator/accelerator program where Veeva is actively engaged as a sponsor, mentor, and judge.
  • FDA 513g: A separate regulatory vehicle (distinct from a pre-submission) used to formally request the FDA to designate the classification of a novel device.

Key Concepts

  • 510(k) (Premarket Notification): The primary pathway for Class II medical devices, requiring demonstration of substantial equivalence to a legally marketed predicate device.
  • De Novo Classification: A pathway for novel, low-to-moderate risk devices (Class I or II) that have no predicate device. It establishes a new classification and special controls for future similar devices.
  • PMA (Premarket Approval): The most rigorous pathway for high-risk, life-sustaining, or life-supporting Class III medical devices.
  • CE Mark (EU MDR): The regulatory approval required to market medical devices in the European Union, governed by the Medical Device Regulation (MDR).
  • Pre-Submission (Q-Submission): A formal, written request to the FDA for early feedback on a device's regulatory pathway, testing plan, and clinical study design, intended to de-risk the final submission.
  • AI Request (Additional Information Request): A formal request from the FDA reviewer during the submission process asking the applicant to provide missing or clarifying data/documentation.
  • Predicate Device: A legally marketed device used as a benchmark in a 510(k) submission to demonstrate that the new device is substantially equivalent in terms of safety and effectiveness.
  • Technical File / Design History File (DHF): The comprehensive set of documentation required by EU and US regulations, respectively, detailing the design, development, manufacturing, and testing of a medical device.