A Unique Look Inside a 510(k) Development and Submission Project
We work on a lot of 510(k) projects—here's a peek behind the curtain.
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We’ve recently had the pleasure of supporting a European biomedical sensor company’s premarket notification via the 510(k) pathway.
For device and medtech firms looking to use this pathway now or in the future, we thought we’d briefly explain what such a project looks like—and reveal some of the under-appreciated aspects of working with experienced consultants for pivotal regulatory projects like this.
If you haven’t already seen our conversation with Trey Thorson on 510(k) FAQs, be sure to check it out below.
To date, this project has primarily involved:
Identifying, analyzing, and documenting numerous product modifications.
Redirecting the regulatory strategy from the Special 510(k) to the Traditional 510(k) submission pathway.
Providing regulatory mentorship and consultancy in navigating the intricacies of submission development.
We assembled a team of regulatory consultants to tackle both the planning and execution phases of the project—a cost-effective and efficient model for project support that has helped the company bypass the administrative costs and practical difficulties typically associated with managing such a project entirely in-house.
Acknowledging the complexity of the 510(k) pathway and the need for specialized expertise in handling what was uncovered to be a larger-than-expected number of modifications to their medical device, the company sought external regulatory assistance in cataloging these changes, crafting a revised regulatory strategy, and navigating the submission process.
The company initially anticipated qualifying for the Special 510(k) pathway with just a few device changes. But after a detailed examination by our regulatory team, over 100 modifications were discovered.
These modifications included mechanical and software changes, re-validation of sterility, the addition of a component requiring a new biocompatibility assessment, additional EMC testing, and human factors testing.
Our approach and solution
Acknowledging the many multifaceted device modifications, we recommended a strategic transition from the Special 510(k) to the Traditional 510(k) pathway.
This decision was a proactive measure to avoid the risk of the FDA triggering a conversion itself due to extensive changes in the device, which we determined surpasses the scope of a Special 510(k) submission.
While the Special 510(k)’s expedited review process is obviously appealing, we determined that pursuing this pathway could have potentially compromised the thoroughness of the company’s submission, considering the substantial modifications made to the device and the absence of comparable data—especially given that new requirements had been added since the device's initial clearance.
A Traditional 510(k) submission, although seemingly more time-consuming, would actually save the company in the long run by eliminating the risk of potential delays caused by a mid-process conversion by the FDA. The Traditional option will ensure comprehensive reports covering all general safety and performance requirements are submitted right from the start, aligning with current regulations.
While the submission will maintain some semblances to a Special 510(k) submission (as a modification of their device), it will ultimately be submitted under the Traditional pathway with full test reports.
To date, the revised submission strategy has involved a joint effort between the company’s in-house regulatory team and our consultants to:
Catalog, analyze, and precisely classify all device modifications.
Determine which specific skillsets were necessary to compile the requisite documentation.
Assign roles to address the extensive documentation needs.
Assist and provide guidance in compiling necessary documentation and constructing the 510(k) submission.
Our team has served as regulatory advisors throughout this process, guiding the in-house regulatory team to undertake the bulk of the documentation and research required for each of the changes.
To manage these many modifications, we meticulously organized all changes into a spreadsheet and individually assessed them using the FDA's guidance flow charts. This ensured a comprehensive understanding and preparation for the eventual submission. We’ve continued supporting the in-house regulatory team in gathering the necessary data and additional documentation required for the new submission.
Currently, one of the primary focus areas is Human Factors Engineering (HFE). We’ve provided the company with an ‘HFE worksheet’ to detail the interactions between the device and its users. Once sufficient details are obtained, a test protocol will be developed to address the critical tasks identified.
For the next stage of the project, we plan to present the company's clinical trial data related to their claims, HFE proof, and sampling plans for validation studies as Q-Submission (Q-Sub) topics. This is to gain verification and concurrence on the planned submission strategy, specifically concerning identifying samples, sampling plans for validating safety and performance, and new anatomical site use claims for the device. The Q-Sub will also incorporate plans regarding the post-transit study samples used to validate performance, accessory concerns, sterility validation claims, and the biocompatibility report.
If the FDA finds the level of detail satisfactory during the Q-Sub, it will likely approve these plans and/or offer advice to adjust them. If there isn't enough data or detailed information, the agency will likely require another Q-Sub to be submitted before proceeding with testing and drafting the final submission.
Results to date and ongoing work
So far, there are some wins to note: The company was successfully redirected to follow the Traditional 510(k) submission pathway, saving it from expensive and time-consuming setbacks and increased scrutiny from the FDA if the Special 510(k) pathway was pursued.
With a regulatory support team that has worked on many similar projects, our team has been able to quickly establish an understanding of the project and direct it toward its goals without further delays. While the project is still ongoing, all external resources assigned have remained committed throughout the engagement, with zero turnover.
Once the current development phase is finished, we plan to continue working with the company through the rest of the 510(k) submission and into postmarket surveillance activities as the project progresses. This process is expected to extend into 2024.
Our typical approach to 510(k) support
The FDA 510(k) submission process is complex and can be challenging for companies, especially those unfamiliar with the regulatory requirements.
Over the many years we've spent helping device firms gain market clearance, we've seen companies realize they need expert help in a number of areas, including but not limited to the following:
Preparation of the Submission: Preparing the required 510(k) documentation involves a complex workstream that can be time-consuming and requires a deep understanding of regulatory requirements.
Summarizing Test Reports: Once test reports are prepared, they must be summarized and applied to the required sections of the 510(k).
Regulatory Strategy: Developing a regulatory strategy that meets FDA requirements and maximizes the chances of clearance. (Success ultimately depends on the quality of the data and information provided by the client.)
Review of Existing Regulations: Reviewing existing regulations and determining the appropriate regulatory pathway for a particular device.
Interaction with the FDA: Providing guidance on preparing and submitting pre-submission documents and scheduling meetings, responding to requests for additional information, and managing other interactions with the FDA.
Below is an expanded explanation of our typical 510(k) support process. This is not a rigid process, and support can be provided in many different ways depending on a firm’s needs and current state.
Phase 1: Introductory Conversation
About Us: Introduction to The FDA Group, outlining our expertise, experience, and approach to FDA regulatory processes, particularly in 510(k) submissions.
About You: We gather comprehensive information about your company, including your experience with medical devices, specific needs, and expectations from the 510(k) process.
Scope of Work: Defining the scope of our collaboration, including setting clear objectives, timelines, and roles and responsibilities for both parties. This phase ensures alignment and sets the foundation for a successful partnership.
Phase 2: Initial Assessment and Regulatory Advisory
Device Description and Analysis: Upon receiving a brief description of your medical device, its intended use, and potential predicate devices, we initiate an in-depth analysis of its FDA regulatory classification.
Regulatory Requirement Identification: We determine the specific requirements for your device's 510(k) submission, focusing on its unique characteristics and regulatory category.
Preparation of Regulatory Advisory Letter (RAL): We compile a comprehensive RAL detailing every document required for the 510(k) application, including technical drawings, product specifications, and test reports. This letter serves as a guideline for your company to prepare the necessary documentation.
Phase 3: Pre-Submission Strategy
Pre-submission Evaluation: While optional, pre-submissions are highly advised in cases where there's no clear predicate device or if there are uncertainties regarding testing requirements.
Collaborative Preparation for FDA Feedback: Working closely with your team, we draft a formal pre-submission request to the FDA. This includes a cover letter, a Premarket Review Submission Cover Sheet, the type of feedback desired, and any specific questions regarding the planned submission approach.
Alignment with FDA Expectations: The pre-submission process is geared towards obtaining the FDA's agreement on key aspects of the application, thereby streamlining the subsequent submission phase.
Phase 4: 510(k) Submission and Review
Document Compilation and Review: Once you provide all relevant documents, we conduct a thorough review to ensure their completeness and compliance with FDA standards. If any documents are found lacking, we will coordinate with your team for necessary revisions or additions.
Application Drafting and Estimation: With all documents in place, we proceed to draft the 510(k) application.
Submission and FDA Review Timeline: After submitting the application to the FDA, the approval process generally takes about 3 to 4 months, although this timeline can vary based on several factors.
Who is The FDA Group?
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With over 2,500 resources worldwide, over 225 of whom are former FDA, we meet your precise resourcing needs through a fast, convenient talent selection process supported by a Total Quality Guarantee.
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