FDA 510(k) Submission Support for Medical Device and IVD Manufacturers

Compliance Management Solutions prepares FDA 510(k) submissions for medical device and IVD manufacturers, from the pathway and predicate strategy to the testing evidence and the submission itself. We also prepare De Novo and premarket approval (PMA) applications, and build technical files that serve the FDA, the EU MDR and the TGA together, so one body of evidence supports several markets.

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What a 510(k) is

A 510(k), or premarket notification, is a submission to the US Food and Drug Administration showing that a device is as safe and effective as, that is substantially equivalent to, a legally marketed device, known as the predicate. The new device must have the same intended use as the predicate, and either the same technological characteristics or different ones that do not raise different questions of safety and effectiveness. It does not have to be identical.

A device found substantially equivalent is cleared, not approved. FDA's regulations state that clearance does not denote official approval, and that any suggestion of approval is misleading. The device cannot be marketed in the US until FDA issues its substantially equivalent order.

Is a 510(k) the right route?

The US classifies devices by risk into Class I, II and III, and the class largely decides the pathway:

Class I and Class II devices need a 510(k) unless they are exempt. Many Class I and some Class II device types are exempt, within limits set in their classification regulations.
Class III devices generally need premarket approval (PMA), the most demanding pathway.
Novel devices with no predicate, where general controls, or general and special controls, would give reasonable assurance of safety and effectiveness (Class I or II), can use the De Novo classification request. A device granted De Novo can then act as a predicate for later 510(k)s.

US classes do not map one to one onto Australian or EU classes, so a device's US pathway needs to be worked out from the FDA classification regulations, not assumed from its class elsewhere.

How we help

Pathway and predicate strategy. Regulatory pathway assessment, device classification and jurisdiction analysis, and a US market entry strategy, ideally before the evidence is generated.
510(k), De Novo and PMA preparation for medical devices and IVDs, including the substantial equivalence comparison and the supporting documentation.
Technical files for several markets. Technical file and design dossier preparation to FDA, EU MDR and Australian requirements, so evidence is written once and reused.
Testing evidence. We assist with testing to recognised standards: electrical safety and EMC, biocompatibility, sterility and performance.
Biocompatibility and risk. Biocompatibility gap assessments and biological evaluation reports against the ISO 10993 series, and ISO 14971 risk management documentation that follows FDA, MDR and TGA requirements.
Usability. Usability reports and usability engineering documentation.

What goes into a 510(k)

There is no 510(k) form; the contents are set by 21 CFR 807 Subpart E. In practice a submission includes:

the device name, classification and product code
the proposed labelling and indications for use
a comparison with the predicate, with data to support the similarities and differences
performance data, which can include non-clinical bench testing and, where needed, clinical data
depending on the device, evidence on biocompatibility, sterilisation, shelf life, software, and electrical safety and EMC
a 510(k) summary or statement, and a statement that the information submitted is truthful and accurate

There are three types: Traditional, which can be used in any circumstance; Special, for changes to a manufacturer's own legally marketed device; and Abbreviated, which relies on guidance documents, special controls and recognised standards. Using FDA-recognised consensus standards is voluntary, but a declaration of conformity to them can support parts of the submission.

Since 1 October 2023, original 510(k)s must be submitted electronically using FDA's eSTAR template through the CDRH Portal, and FDA has said it does not intend to grant waivers. Inaccurate answers inside the eSTAR can put a submission on hold early, so the template needs the same care as the evidence.

FDA review and timing

The review process runs in stages:

Screening. FDA checks the user fee and the submission format. eSTAR submissions go through technical screening rather than the refuse-to-accept checklist, and an incomplete eSTAR is placed on hold.
Substantive review. The lead reviewer examines the submission and contacts you, which should occur within 60 calendar days of receipt.
Additional information, if needed. The submission goes on hold. FDA's policy is to allow 180 calendar days to respond, with no extensions; after that the 510(k) is considered withdrawn.
Decision. Substantially equivalent (cleared) or not substantially equivalent.

Under MDUFA V, FDA's goal is a decision on 95% of 510(k)s within 90 FDA Days. FDA Days exclude the time a submission spends on hold, so the calendar time depends heavily on the quality of the first submission. FDA's optional Pre-Submission Program lets you ask for its feedback before testing begins; it is voluntary and does not guarantee a favourable decision.

A user fee applies to every type of 510(k), and qualifying smaller businesses can apply for reduced fees, renewed each US fiscal year. Fees change every 1 October, so check FDA's current schedule rather than a figure quoted elsewhere.

Beyond the 510(k)

Clearance is one of several US obligations, and a foreign manufacturer should plan for all of them:

Registration and listing. Foreign establishments making devices for the US must register with FDA and list their devices, and renew registration each year between 1 October and 31 December.
A United States agent. Each foreign establishment must designate one US agent who resides or has a place of business in the US.
Quality management system. Since 2 February 2026, FDA's Quality Management System Regulation incorporates ISO 13485:2016 by reference. FDA does not typically inspect before clearance, but a manufacturer should be ready for an inspection at any time after it. See our ISO 13485 page.

Using a 510(k) in Australia

The TGA recognises the US FDA as a comparable overseas regulator, and its guidance lists 510(k) and PMA decisions among the evidence it considers for ARTG inclusion. The TGA pairs FDA product evidence with manufacturer evidence, such as an MDSAP certificate, and some applications must still be audited. We can plan the US and Australian submissions together. See our ARTG inclusion and TGA conformity assessment pages for the Australian side.

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Frequently asked questions

Is a 510(k) the same as FDA approval?

No. A device that receives a substantially equivalent decision through the 510(k) process is cleared, not approved. FDA regulations state that clearance does not denote official approval, and that implying approval is misleading. Approval is the term for the premarket approval (PMA) pathway used for most Class III devices.

How long does FDA take to review a 510(k)?

FDA's goal under MDUFA V is a decision on 95% of 510(k)s within 90 FDA Days. FDA Days stop while a submission is on hold for additional information, so the calendar time is longer and depends on how quickly any deficiencies are answered. FDA allows 180 calendar days to respond to an additional information request, with no extensions.

What if there is no suitable predicate device?

A 510(k) needs a legally marketed US predicate. Where none exists and general controls, or general and special controls, would be enough to assure safety and effectiveness (a Class I or II device), the De Novo classification request is the usual route. Where the device is high risk, a premarket approval (PMA) application is likely to be needed. Choosing the pathway before generating evidence avoids testing to the wrong plan.

Can an Australian manufacturer submit a 510(k)?

Yes. FDA lists foreign manufacturers introducing a device to the US market among those who submit 510(k)s. Separately, a foreign establishment must register and list its devices with FDA, and designate a United States agent who resides or has a place of business in the US.

Can a 510(k) help us get onto the ARTG?

It can. The TGA recognises the US FDA as a comparable overseas regulator, and its guidance lists 510(k) decisions among the evidence it considers. In the TGA's guidance, FDA product evidence is paired with manufacturer evidence such as an MDSAP certificate, and the ARTG application may still be selected for audit.

Do 510(k)s have to use eSTAR?

Yes. Since 1 October 2023, original 510(k) submissions must be made electronically using FDA's eSTAR template, unless exempted, and FDA has said it does not intend to grant waivers. Submissions go through the CDRH Portal.