FDA 510(k) Consulting Services

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?

Don't let the recent changes at the FDA prevent your product from clearance.

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.

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.

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

Former FDA reviewers and industry veterans

Gain insider insight from professionals who’ve worked within the FDA and understand its processes from the inside. We help anticipate reviewer expectations, avoid common pitfalls, and communicate effectively with the agency.

Proven expertise across the 510(k) landscape

Our consultants have completed hundreds of 510(k) submissions across all device classifications. With a 97% satisfaction rate and a 95% "right resource, first time" success rate, we're a trusted partner for medtech companies ranging from startups to global enterprises.

Personalized support, every step of the way

You’ll get a dedicated account team that stays with you throughout the engagement, offering personalized support, clear communication, and fast responses to your needs.

Speed without sacrificing quality

We work quickly—often launching new engagements within days—while maintaining strict attention to detail. Our streamlined approach ensures your submission stays on track.

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.

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

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.

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.

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

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.

510(k) Consulting Services 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.