510(k) Consulting Services for Medical Devices Get rapid access to the industry's best 510(k) consultants and move your product to market.

    FDA clearance is critical for the market success of your medical device. At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our bench of regulatory affairs talent has extensive experience and knowledge, with some having worked directly with and within FDA. 

    We carefully deploy time-tested best practices during each step of the regulatory process, helping you maximize the likelihood of obtaining market clearance without delay. Our deep bench of regulatory experts covers every dimension of expertise required to make the 510(k) clearance a success, no matter where you are in the process.

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    Contact us for expert 510(k) assistance.

    Use the form below to tell us more about your regulatory needs. We'll follow up within one business day.


    Experienced 510(k) consultants

    Unlike other regulatory consulting firms whose consulting bench may consist of less-experienced experts, each of our 510(k) consultants has an extensive track record of success, ensuring you get the knowledge and expertise you need to successfully gain market clearance. Simply put, we deliver better talent, faster and more cost-effectively than traditional firms.

    Industry and former FDA professionals

    Our consulting network contains a mix of regulatory professionals, some of whom are former FDA personnel. Their unique understanding of the FDA’s review process and expectations enables us to handle our clients' submissions with the utmost expertise and attention to detail. Our insider perspective and decades of combined experience give us the edge to help our clients navigate the complex 510(k) submission process.

    Unparalleled client success and satisfaction

    Our 95% client success rate and 97% client satisfaction rate speak for themselves. Our clients trust in our expertise to guide them through the submission process. With us as your consulting partner, you'll get a refreshingly personalized approach, clear communication, and attention to detail — three elements that are becoming increasingly hard to find. It's what makes us the preferred choice for 510(k) consulting services.

    Why you need an expert 510(k) consultant

    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.

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    510(k) Regulatory Submission Services

    A skilled 510(k) consultant is instrumental in guiding you through the process of obtaining clearance for medical devices that require a 510(k). Our consultants make sure what's often a complex and fraught process is navigated smoothly by thoroughly understanding the device and anticipating any potential obstacles. With the help of highly qualified and experienced experts, the clearance process can be completed with a much higher likelihood of success.

    Each specific 510(k) consulting engagement is tailored precisely to your needs and can include, but is not limited to:

    • Regulatory strategy development

      Assistance in determining the most appropriate regulatory pathway and the preparation of a comprehensive regulatory strategy.

    • Preparation of 510(k) submissions

      Writing and compiling the 510(k) submission.
    • Review and analysis of the device and its predicate

      Determining the device's classification and the applicable predicate device(s).

    • Interaction with the FDA

      Facilitating communication with FDA, including responding to agency questions and requests for additional information.

    • Support throughout the review process

      Monitoring the review status, providing guidance and support throughout the review process, and managing any necessary post-submission activities.

    • Post-clearance support

      Providing ongoing regulatory support for post-approval changes, periodic reporting, and maintenance of device marketing clearance.


    A sample of specific 510(k) consulting activities

    Here are some of the specific 510(k) activities we can assist with:
    • Determining the appropriate predicate device through consultation with the manufacturer
    • Determining device class, product code, and regulation number
    • Determining any necessary usability/human factors requirements
    • Assisting with the device listing and registration
    • Preparing pre-submissions to obtain FDA's alignment on the predicate strategy
    • Preparing FDA's "Refuse to Accept" documentation
    • Evaluating labeling requirements and reviewing labels
    • Reviewing device-specific documentation such as software, EMC, and electrical safety
    • Determining biocompatibility test requirements
    • Determining performance test requirements per applicable standards
    • Identifying the applicable type of 510(k) submission for your device
    • Finalizing 510(k) file
    • Considering pre-submission
    • Submitting e-copy/eStar
    • Communicating with FDA

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    Expert 510(k) Insights Navigating the 510(k) process: A Q&A with The FDA Group

    Watch our Q&A with one of our experienced regulatory consultants, where we address some of the most frequently asked questions about navigating the 510(k) premarket notification process.

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    510(k) Case Study Guiding 510(k) Preparation and Submission for U.S. Medical Device Market Clearance

    Learn how The FDA Group supported a European biomedical sensor company’s
    FDA premarket notification via the 510(k) pathway by redirecting its regulatory strategy to the optimal market clearance pathway, providing expert guidance to a small in-house regulatory team, and engaging with regulators.

    Read the case study (PDF) »

    Let's bring your product to market and keep it there.

    Contact us today to take the first step toward bringing your product to market quickly and efficiently. A flawed submission will cause delays and hold up your product launch for several months—perhaps longer.

    Our 510(k) consultants will give you individualized support to maximize the likelihood that your submission is successful and delay-free. Our bench of regulatory affairs talent has extensive experience and knowledge, with some having worked directly with and within FDA. They will share their expertise with you throughout the review process, providing a level of service and professionalism that's hard to find elsewhere.

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    Why work with The FDA Group?

    • Exclusive life science focus and expertise
    • Dedicated account management team
    • Right resource, first time (95% success)
    • 97% client satisfaction
    • Total Quality Guarantee

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    Our Proven 510(k) Process

    Introductory Conversation

    • About Us
    • About You
    • Scope Of Work

    Initial Assessment and Regulatory Advisory

    • Device Description and Analysis
    • Regulatory Requirement Identification
    • Preparation of Regulatory Advisory Letter (RAL)

    Pre-Submission Strategy

    • Pre-Submission Evaluation
    • Collaborative Preparation for FDA Feedback
    • Alignment with FDA Expectations

    510(k) Submission and Review

    • Document Compilation and Review
    • Application Drafting and Estimation
    • Submission and FDA Review Timeline

    Learn more about our 510(k) process

    Below is an expanded explanation of our typical 510(k) support process. Please note that this is not a rigid process, and support can be provided in many different ways depending on your 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 your company provides 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.

    Contact us and get the conversation started.

    Use the form below to tell us more about your 510(k) consulting needs. We'll follow up within one business day.