FDA 510K Submission

When is a 510(k) Submission Required?

You must submit a 510(k) to the FDA if:
Your device is not exempt and is not already legally marketed in the U.S.
You’re making a significant change or modification to a previously cleared device that could impact its safety or effectiveness.

What the 510(k) Submission Involves
Preparing a compliant 510(k) submission includes:
Identifying a suitable predicate device
Compiling technical documentation
Conducting bench tests, biocompatibility tests, and clinical evaluations (if required)
Aligning with FDA-recognized consensus standards
Drafting the submission file in accordance with 21 CFR 807.87
Creating an FDA-compliant eCopy for submission
Typical Timelines
Document preparation: 4 to 5 months, depending on device complexity and data requirements
FDA review period: Up to 6 months, including time for addressing potential review queries
The Role of a 510(k) Consultant
Engaging a knowledgeable FDA 510(k) consultant can dramatically:
Reduce the risk of Refuse to Accept (RTA) issues
Minimize additional information requests
Help you navigate FDA communication protocols smoothly
Accelerate your pathway to clearance
🇺🇸 US Agent Requirement for Foreign Manufacturers
All non-U.S. medical device manufacturers must designate a US Agent to handle official correspondence with the FDA.
Note: This service differs from the US Agent service used for FDA establishment registration.
RAPS provides end-to-end 510(k) submission support, including documentation, regulatory strategy, and US Agent representation—ensuring your device reaches the U.S. market with confidence and compliance.

FDA Pre-Submission (Q-Sub) Program for 510(k) Applications
The FDA Pre-Submission (Q-Sub) Program offers medical device manufacturers the opportunity to receive early feedback from the FDA before submitting a formal 510(k) application. This valuable program helps clarify expectations, reduce submission delays, and improve the quality of your final submission.
Why Consider a Q-Submission?
A Q-Sub is ideal when you need guidance on topics such as:
Appropriate test methods or standards (e.g., biocompatibility, safety, performance testing)
Substantial equivalence determination
Regulatory pathway decisions
Addressing specific technical challenges or uncertainties
What’s Included in a Q-Sub Request?
To initiate a Pre-Submission, manufacturers must submit a written request that includes:
A clear device description and intended use
Summary of any regulatory history
A detailed list of specific questions for the FDA
Any supporting data or documentation
What Happens After Submission?
The FDA typically responds within 60–75 days, offering a teleconference or in-person meeting.
The meeting allows for open discussion of your submission strategy and technical concerns.
Post-meeting, you’ll receive formal written feedback—helping shape a stronger, more focused 510(k) submission.
How RAPS Can Help
Our regulatory consultants work closely with you to:
Draft a compelling, complete Q-Sub request
Frame precise, actionable questions for the FDA
Prepare you for the Q-Sub meeting and FDA interaction
Integrate FDA feedback into your final 510(k) strategy
Start smarter with a Pre-Submission. RAPS ensures you're aligned with FDA expectations before you even submit. Ready to reduce risk and move forward with confidence?

Benefits of the FDA Pre-Submission (Q-Sub) Program
While a Pre-Submission (Q-Sub) is not mandatory, it is often highly recommended—especially for complex or innovative devices. At RAPS, we encourage clients to take advantage of this program to gain early FDA insights and reduce regulatory uncertainty.
Why Use the Pre-Submission Pathway?
Engaging in a Q-Sub helps you:
Obtain preliminary FDA feedback on test strategies, substantial equivalence, or regulatory classification
Avoid unnecessary or costly testing, such as bench, animal, or clinical studies that may not be required
Clarify FDA expectations before investing in time-consuming protocols or studies
Address potential deficiencies before submitting your 510(k)
Improved Submission Quality, Faster Clearance
By aligning with FDA expectations early, manufacturers can:
Enhance the quality and completeness of the final 510(k) submission
Minimize review cycle delays due to missing or unclear data
Significantly reduce the risk of RTA rejections or major review comments
Potentially shorten the total review timeline, speeding up market entry
Ask the Right Questions, Get Better Feedback
While FDA feedback during a Q-Sub is non-binding, it often strongly reflects the agency’s expectations. To get the most value:
Carefully frame your questions to be specific, focused, and actionable
Provide well-organized supporting documentation to guide FDA responses
How RAPS Adds Value
Our consultants:
Strategically develop Q-Sub packages that highlight key regulatory concerns
Help formulate the right technical and regulatory questions
Ensure your request is clear, complete, and aligned with your 510(k) goals
Prepare and support you for the actual FDA interaction
Plan smart. Submit strong.
Let RAPS guide your Pre-Submission process and ensure your FDA 510(k) journey starts on solid ground.

FDA 510(k) Submission: Your Gateway to U.S. Market Entry

When is a 510(k) Submission Required?

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