US FDA 510(K)
Consulting
Overview
Filing a Premarket Notification (510(k)) with the U.S. Food and Drug Administration (FDA) is typically required before marketing many medical devices in the United States. This is most commonly required for Class II devices (including many in vitro diagnostics), some Class I devices, and many unclassified (pre-amendment) devices. The 510(k) process doesn’t “approve” a device; it provides FDA clearance when the device is found substantially equivalent to a legally marketed predicate device.
Who must submit a 510(k)?
Manufacturers planning to introduce Class II devices and certain Class I or unclassified devices into the U.S. must submit a 510(k). A new 510(k) is also required when changes to intended use or technology could significantly affect safety or effectiveness, even if the change is an improvement.
MDRA's 510(k) support approach
MDRA uses a two-step, collaborative approach to prepare successful 510(k) submissions. This method is cost-effective and reduces the risk of FDA denial. Since 2018, MDRA has helped clear hundreds of devices, including implants, SaMD, and IVDs.
Step 1 — Requirements evaluation, documentation review, and gap analysis
Determine product code and regulation number based on intended use, design, and technology; identify applicable guidance and consensus standards.
- Identify potential predicate devices with existing 510(k) clearance for substantial equivalence.
- Provide a tailored list of required documents, tests, labeling, and other submission elements.
- A U.S. regulatory consultant reviews submitted information for suitability.
- Deliver a detailed gap analysis report that identifies missing or incomplete items needed to finish the 510(k).
Note: MDRA can assist to close identified gaps; that work is scoped as a separate project.
Step 2 — 510(k) compilation and FDA submission
Once all materials are available, MDRA will:
- Prepare a technical comparison showing substantial equivalence to the selected predicate(s).
- Draft all sections of the 510(k) for your review and approval.
- Electronically submit the 510(k) to the FDA and act as the official correspondent for communications.
- Coordinate payment of FDA submission fees if requested.
- Promptly relay FDA communications and assist in responding during Acceptance Review, Substantive Review, and Interactive Review.
MDRA’s goal is to help you successfully introduce your device to the U.S. market through experienced regulatory and quality support.
Will I receive a registration certificate after 510(k) clearance?
No. The FDA issues a 510(k) clearance letter and posts it on its website; that posting is the official proof of clearance.
How long is 510(k) clearance valid?
Clearance does not expire provided the device, intended use, and indications remain unchanged. Significant changes must be assessed against FDA guidance to determine if a new 510(k) is required.
If a predicate exists, do I need the same testing?
You must submit performance testing that supports substantial equivalence—often comparative testing against the predicate. Some product codes follow the FDA’s “Safety and Performance Based Pathway,” which defines expectations. If animal or clinical data may be needed, consider an FDA pre-submission (Q-submission) to clarify testing requirements.
How long does 510(k) clearance take?
FDA’s goal is a 90-day review, but typical total timelines range from four to nine months or longer. Delays often result when the FDA requests additional information — the agency’s review clock pauses while you respond. Timeline drivers include the quality of technical documentation, predicate selection, and the need for additional testing or data.
Can a 510(k) be transferred? Who owns it?
The 510(k) sponsor (the owner) is the party listed on the submission. Ownership may differ from the manufacturer. When ownership transfers (e.g., acquisition), the buyer updates their establishment registration, which is generally sufficient to notify the FDA. Changes to the manufacturing site require process validation under the company’s QMS and registration of the new facility.
What is a device family and when can devices be included in one submission?
Multiple devices may be bundled in a single 510(k) if supporting data are similar, the same FDA review group would review them, and the devices or indications are comparable. This can include device-accessory groupings, devices for the same intended use made from different materials, etc.
Is home-country approval required for devices made outside the U.S.?
No, home-country approval is not required for FDA clearance.
If you’d like, MDRA can perform an initial 510(k) requirements evaluation and gap analysis for your device.
CE Mark EU MDR 2017/745 & EU IVDR 2017/746
Clinical Evaluation (CEP & CER)
