510(k) Regulatory Submissions for Medical Devices Get rapid access to the industry's best 510(k) consultants and move your product to market—even as changes affect the FDA.

    FDA clearance is critical to the success of your medical device. With reductions in workforce at the FDA potentially affecting reviewer bandwidth, it's more important than ever to start early, plan smart, and work with seasoned experts who know the 510(k) process inside and out.

    At The FDA Group, we connect you with the industry's top regulatory consultants—including former FDA professionals—to help you move confidently through the 510(k) submission process.

    We tailor every engagement to your needs and provide the strategic guidance, technical expertise, and regulatory insight you need to secure clearance efficiently, even in the face of FDA review delays.

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    Please complete the information below to express your 510(k) needs so we can best provide assistance with your project. We'll follow up within one business day.

    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.

     

    Don't let the recent changes at the FDA prevent your product from clearance. Review times are proceeding normally.

    We are helping firms bring their products to market right now.

    Recent staffing reductions at the FDA have raised concerns across the industry about longer submission timelines. Some companies are considering delaying their 510(k) projects—but waiting is often leading to longer delays and missed market windows. The smartest teams are acting now to:

    • Develop airtight regulatory strategies aligned with current FDA expectations.

    • Begin documentation and testing early to avoid bottlenecks.

    • Submit pre-submissions to secure alignment and reduce the risk of RTA.

    Let’s talk about how we can help you move forward confidently.

    Immediate 510(k) readiness review

    We rapidly evaluate your device's readiness and provide clear recommendations to align your submission strategy with current FDA expectations. Our early-stage assessments uncover risks and reduce uncertainty right now.

    Accelerated documentation and pre-submission support

    Our consultants move fast to help you gather, organize, and refine your submission documentation. We guide you through pre-submissions to establish early alignment with the FDA and maximize your chances of a smooth review.

    Future-proof regulatory guidance

    With insight from former FDA personnel, we ensure your submission strategy considers both the current regulatory environment and anticipated future shifts. This positions your device for success even as review dynamics evolve.

    Submission strategy The case for not delaying submissions in 2025

    Worried about the impact of the FDA's recent reduction in force on your premarket submission? Watch our recent interview with one of our senior 510(k) consultants, where he shares what he's seeing with submissions and why he's advising firms to submit now, not later. Long story short: MDUFA-funded FDA reviews are proceeding normally and without delay.

    Click to expand What FDA staffing challenges mean for your 510(k) in 2025

    In 2025, a new variable has entered the equation for firms looking to use the 510(k) pathway: FDA staffing and review constraints. As device firms across the country gear up for new submissions or prepare for U.S. market entry, many are asking the same question: 

    “Should we move forward with our 510(k) submission or wait until things settle down at the FDA?”

    The short answer, based on what we're seeing firsthand as a liaison between industry and regulators, is don't wait—move forward if you're sure your submission is as strong as it possibly can be.

    Understanding the current FDA bottleneck

    It’s no secret that the FDA—particularly its Center for Devices and Radiological Health (CDRH)—has faced staffing shortages and hiring challenges with the recent reduction in force. While the agency continues to operate, we're hearing a lot of concern that these internal pressures may lengthen review timelines and increase scrutiny across certain submission types. Although official guidance remains unchanged,  medical device sponsors are beginning to worry about:

    • Longer wait times for feedback on pre-submissions (Q-submissions)

    • Slower response rates to clarification requests

    • Extended review periods for certain 510(k) submissions, particularly those involving novel technologies or unclear predicates

    While these developments have created uncertainty, prompting some device firms to pause or delay their submission timelines, we have not experienced delays with the teams whose 510(k) we're supporting. We're advising firms not to delay. 

    Why delaying your 510(k) submission may actually backfire

    It’s understandable to want to wait for a “better” window to submit your 510(k)—but in most cases, waiting only increases risk. Here's why:

    Review queues may only get longer.

    As more companies delay submissions or push timelines into later quarters, the pileup of applications is growing. That means if you wait, you may be entering an even more crowded system. Simply put, the FDA is ready for your review now, but likely won't be in a few months.

    Your competitors aren’t waiting.

    The companies most likely to win market share in the coming year are those moving forward now—gaining early insights from pre-subs, addressing FDA feedback proactively, and maintaining momentum toward clearance.

    You can’t control the FDA, but you can control your readiness.

    While the FDA’s timeline may be outside your control, your internal preparation, documentation quality, and regulatory strategy are not. Companies that use this time to strengthen their submissions are better positioned to handle delays and respond swiftly to FDA queries.

    What a proactive 510(k) strategy looks like in 2025

    Instead of viewing the current regulatory environment as a reason to stall, high-performing teams are using it as a signal to start earlier and prepare smarter.

    Here are three ways to do just that:

    1. Align your regulatory strategy early

    Before you build your submission, build your strategy. This includes identifying the correct predicate device, regulatory pathway, and classification—and ensuring these align with FDA's current expectations. A misaligned strategy is one of the most common reasons submissions get rejected or significantly delayed.

    2. Engage in pre-sub dialogue

    Even if review timelines are longer, a well-executed pre-submission (Q-sub) can help ensure you’re on the right path. It gives you the chance to ask key questions, confirm your predicate, and receive informal feedback from the FDA before you invest in a full submission. Getting alignment early saves weeks or months of revisions later.

    3. Create submission-ready documentation now

    Don’t wait to get your documentation in order. Preparing technical files, test summaries, labeling, and risk documentation in advance allows you to move fast when the time is right—and gives you time to fix any gaps before they become show-stoppers. Submission quality is a major factor in review time—especially under current constraints.

    Final thoughts

    It’s a complex time for 510(k) sponsors—but not a time to sit still. Proactivity, preparation, and the right guidance can make all the difference between a delayed product and a market-ready one. If you’re evaluating your regulatory path and want help navigating today’s challenges, now is the time to start the conversation.

    Looking to prepare your 510(k) strategy with confidence?

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    Why work with The FDA Group for your 510(k)?

    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, w    e deliver better talent faster and more cost-effectively than traditional firms.

    200+ former FDA personnel

    Our consulting team includes former FDA personnel who bring a wealth of experience and insider knowledge to the table.

    With their unique understanding of the FDA's review process and expectations, our clients rest assured that their submissions will be handled 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 and achieve successful clearance in a timely manner.

    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 in large, established regulatory firms. It's what makes us the preferred choice for 510(k) consulting services.

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    • The FDA Group, LLC, Compliance Consulting, Westborough, MA
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    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 Technical Documentation: Preparing the technical documentation, including preclinical and clinical study reports. This is often time-consuming and requires a deep understanding of the regulatory requirements.

    • Regulatory Strategy: Developing a regulatory strategy that meets FDA requirements and maximizes the chances of approval.

    • Review of Existing Regulations: Reviewing existing regulations and determining the appropriate regulatory pathway for a particular device.

    • Interaction with the FDA: Interacting with the FDA and responding to requests for additional information — especially for companies without previous regulatory experience.

    • Quality System Requirements: Ensuring that the company's quality system meets FDA requirements and documenting these requirements in the 510(k) submission.

    • Clinical Evaluation: Performing a clinical evaluation that meets FDA requirements and demonstrating the substantial equivalence of a device to a predicate device.

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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 Class I, II, or III medical devices. 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 faster with a much higher likelihood of first-submission 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, including all required regulatory documents, such as technical files, clinical data, and performance data.

    • Review and analysis of the device and its predicate

      Performing a risk analysis and determining the device's classification and predicate device.

    • 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-approval/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

    • Determine the appropriate predicate device through consultation with the manufacturer
    • Determine device class, product code, and regulation number
    • Review FDA's "Refuse to Accept" policy for 510k acceptance
    • Prepare a 510(k) summary and compare to the predicate device
    • Evaluate labeling requirements and review label
    • Review device-specific documentation such as software, EMC, and electrical safety
    • Determine sterilization requirements and provide necessary documentation
    • Determine any necessary clinical data/test requirements
    • Determine biocompatibility test requirements
    • Compile the Declaration of Conformity
    • Determine performance test requirements
    • Develop a Sampling Plan
    • Assess stability study needs
    • Identifying correct type of 510(k) submission
    • Write Indication for Use statement
    • Select relevant guidance and control documents
    • Finalize 510(k) file
    • Review risk management file
    • Consider pre-submission
    • Submit e-copy
    • Communicate with FDA
    • Ensure device listing and registration

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    Book a 510(k) call with us directly

    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 ensure your submission is successful and the certification process is faster. Our bench of talent has extensive experience and knowledge, having worked directly with and within FDA. They will share their expertise with you throughout the review process.

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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 Process

    Introductory Conversation

    • About Us
    • About You
    • Scope Of Work

    Resources Definition

    • Background And Expertise
    • Location Of Resource
    • Rate Rightsizing

    Proprietary Resource Selection Process

    • Recruiting Team External Search
    • In-House Subject Matter Experts
    • Resource Identification

    Resource Presentation

    • CV And Rate
    • Perfect Match Summary
    • Interview Call Coordination

    Agreement Processing

    • MSA And Addendums
    • Supplier Qualification
    • Kickoff Coordination

    Account Management

    • Project Management Of Resource
    • Satisfaction Management For Client
    • Total Quality Guarantee

    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.

     

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    Interested in learning more about our 510(k) services and prefer to book a meeting directly? Use our scheduler below.

    A few typical 510(k) inquiries we receive

    • "Our small company manufactures a home therapy device. We are moving to get a 510(k) FDA clearance. We are looking to contract with a firm that can guide us and advocate for us through the process. Can you help?"

       

    • "My firm needs help submitting our 510(k) application for a device we're looking to bring to market. I had a colleague help me start the submission, but they're not an expert."

    • "We are a startup that intends to import Class II medical products and sell them in the U.S. We would like help filling out the 510(k) and navigating the submission process."

    • "I represent a foreign manufacturer looking to enter the U.S. market with our Class II device. We need assistance understanding the FDA's requirements for foreign manufacturers, including the 510(k) submission process and U.S. agent representation."

    • "We are nearing the commercialization phase for a predicated device. We require comprehensive support in preparing and including regulatory strategy development and clinical data evaluation."
    • "Following an unsuccessful 510(k) submission, we're looking to re-strategize and submit again. We need a firm with a proven track record of overcoming such challenges to guide us through the resubmission process."