Project-based service

FDA 510(k) Premarket Notification

The 510(k) is the premarket pathway for most Class II and some Class I devices: demonstrating to the FDA that your device is substantially equivalent to a legally marketed predicate. We support the full project from strategy to clearance.

RegulatorU.S. FDA (CDRH)

FormateSTAR electronic template

Overall TimelineAbout 10-14 months

AcceptanceRTA completeness screening

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What this service is

A 510(k) premarket notification is a technical submission to the FDA demonstrating that the device to be marketed is substantially equivalent in safety and effectiveness to a legally marketed predicate device. Devices that are not exempt must obtain 510(k) clearance before U.S. marketing.

Since October 2023, all 510(k)s must be submitted using the eSTAR electronic template. After filing, the FDA runs an acceptance screening (RTA check) before substantive review. Significant changes to a legally marketed device that could affect safety or effectiveness can also trigger a new 510(k).

FD&C Act §510(k)21 CFR Part 807 Subpart EMDUFA

Who needs it

Manufacturers whose devices are not 510(k)-exempt and who plan to enter the U.S. market

Companies whose marketed devices underwent significant design or indication changes requiring a new submission

Companies needing integrated support across predicate selection, gap analysis, testing planning, and eSTAR submission

Prerequisites and sequence

Device classification, product code, and regulation number are confirmed, and the device is not 510(k)-exempt.
A manufacturing and records system compliant with the FDA quality system regulation (QMSR / 21 CFR Part 820) is in place or being established.
Required testing is completed or planned per device type — performance, biocompatibility (ISO 10993), electrical safety (IEC 60601), software and cybersecurity, as applicable.
Evaluate in advance whether a Pre-Submission (Q-Sub) meeting is advisable before filing.

Who holds regulatory responsibility

The 510(k) applicant is the manufacturer or specification developer, responsible for the authenticity of the submission and test data. We own submission strategy, document drafting, testing coordination, and FDA review communication support; you own samples, testing execution, and technical decisions.

Materials we need from you

Device description, intended use, and indications

Candidate predicate device information (we help research and confirm)

Risk management file (risk analysis)

Performance, biocompatibility, electrical safety, and other test reports (as applicable)

Labeling and instructions for use (IFU)

Overview of the company's quality system

Process

01
Confirm classification, regulation number, and pathway (510(k), De Novo, or other)
02
Research and select the predicate device; run the substantial equivalence gap analysis
03
Define the testing plan and coordinate sample testing (Q-Sub pre-submission first if warranted)
04
Draft the 510(k) technical file and integrate testing and clinical data (if applicable)
05
Submit in eSTAR format via the CDRH portal and pay the review fee
06
Track acceptance (RTA) screening and substantive review; respond to FDA additional information requests
07
After clearance, connect to establishment registration and device listing

Deliverables

Submission strategy and predicate analysis report

Complete 510(k) submission in eSTAR format

Response documents for FDA review inquiries

Post-clearance market-entry checklist

Timeline

File preparation typically takes about 4-5 months including testing and data consolidation. After submission, the FDA's performance goal is 90 FDA review days, but actual averages run longer. Plan for roughly 10-14 months end to end; a Pre-Submission (Q-Sub) adds about 3 months.

Scope

What we provide

Pathway and predicate analysis
Testing requirement identification and lab coordination
510(k) drafting and eSTAR submission
RTA and additional information (AI) response support
Post-clearance registration and listing coordination

What is not included

The FDA review fee (paid to the FDA per fiscal-year schedule; reduced rates available with small business certification)
Third-party laboratory testing fees
Clinical trial execution (assessed separately if needed)
QMSR / 21 CFR Part 820 system implementation (separate engagement)

What usually follows

FDA Establishment Registration Device Listing

Common pitfalls

Incomplete file placed on RTA holdAt acceptance screening the FDA checks the submission against a completeness checklist; deficiencies put the file on RTA hold, requiring correction and resubmission within 180 days with the review clock reset. A complete, well-mapped file is the key to avoiding RTA.

Skipping the Q-Sub when the testing strategy is uncertainFor products with uncertain testing strategy, a Q-Sub provides written FDA feedback before filing at no user fee. Committing to testing in the wrong direction without that feedback makes later rework far more expensive.

Not assessing whether device changes trigger a new 510(k)Significant design or indication changes to a legally marketed device that could affect safety or effectiveness trigger a new 510(k). Skipping this assessment in change management means marketing without clearance.

Applying for small business certification only when the fee is dueSmall business certification is a separate application granted per tax year; without it in hand before the review fee is paid, the standard rate applies. Plan the certification ahead of any 510(k) filing.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

What happens if the FDA refuses to accept the submission (RTA)?

At acceptance screening, incomplete submissions are placed on RTA hold; deficiencies must be fixed and the file resubmitted within 180 days, and the review clock resets. A complete, well-mapped submission is the key to avoiding RTA — that is what our preparation phase is designed to control.

What is a Q-Sub pre-submission, and is it worth it?

A Q-Sub lets you obtain written FDA feedback on testing plans, equivalence arguments, and similar questions before filing, at no user fee. For products with uncertain testing strategy it can prevent spending on the wrong studies later; the trade-off is roughly 3 months added to the overall timeline.

If the decision is NSE (not substantially equivalent), are there other options?

Depending on the situation, you can resubmit with stronger data, request De Novo classification, or evaluate the PMA pathway. We aim to surface these risks as early as the strategy phase.

Can small businesses get a reduced review fee?

Companies qualifying as an FDA small business (gross receipts or sales of no more than USD 100 million in the most recent tax year, including affiliates) can obtain small business certification and pay the reduced 510(k) review fee. Certification is a separate application we can assist with.

Related services

Establishment RegistrationManufacturers, initial importers, specification developers, and other establishments that intend to market medical devices in the U.S. must complete annual establishment registration with the FDA under 21 CFR Part 807 and pay the annual registration fee. We support classification checks, filing, and annual renewal.Small Business ApplicationCompanies meeting the revenue threshold can apply for FDA small business certification, unlocking substantially reduced MDUFA user fees for 510(k) and other submissions. We prepare the forms and handle CDRH portal submission.Device Label ReviewWe review primary and secondary device labels against FDA labeling regulations (21 CFR Part 801 and related rules), flag non-compliances, and recommend corrections — reducing misbranding and port detention risk.Device U.S. AgentThe FDA requires foreign device establishments to designate an agent located in the United States as its routine point of contact. We serve as your U.S. Agent on an annual basis, handling FDA communication, registration maintenance, and inspection coordination.

Disclaimer

510(k) outcomes are decided by the FDA; no service provider can guarantee clearance. Timelines stated here are general references and depend on product complexity, testing, and FDA review. This service is not legal advice.