[ HOW-TO GUIDE ]

How to Choose a US Device Premarket Pathway

Decide between 510(k), De Novo and PMA, and test the decision with FDA before committing to the testing.

What a how-to is not

A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.

The premarket route for a medical device follows from its classification, its intended use and whether a legally marketed predicate exists. Getting it wrong costs a not-substantially-equivalent decision or months of testing to the wrong standard. This sequence settles the route, tests it with FDA through a Pre-Submission, and builds the submission in the format FDA requires.

WORK THROUGH THESE STEPS IN THE TEMPLATE
Q-Submission (Pre-Sub) Request
Each step below has a place in SPEQ’s structured, regulator-aligned template for this procedure. Open the template →
THE STEPS
  1. 1

    Write the intended use first

    Draft the intended use and indications for use before anything else: patient population, condition, setting, prescription or over-the-counter. Every later step is judged against it, and a broader claim can change the classification.

  2. 2

    Find the classification

    Identify the classification regulation and product code that fit the intended use. Where nothing fits or the answer is disputed, a 513(g) request for information asks FDA for its view.

  3. 3

    Test for a predicate

    For class I or II devices that are not exempt, look for a legally marketed device with the same intended use and comparable technology, and test it against 807.100(b): the same technological characteristics, or different ones that do not raise different questions of safety and effectiveness. A credible predicate means a 510(k).

  4. 4

    Choose De Novo or PMA where there is no predicate

    If there is no predicate but general and special controls can manage the risks, the route is De Novo under Part 860; propose special controls you are content to see become the regulation. Class III devices that require premarket approval go through a PMA under Part 814.

  5. 5

    Ask FDA before testing

    Submit a Pre-Submission with the route, the predicate or classification rationale, and the testing and clinical plan, asking 7–10 specific questions across no more than four topics, as the May 2025 Q-Submission guidance advises. FDA targets written feedback within 70 days; draft and submit meeting minutes within 15 days of any meeting.

  6. 6

    Build the submission in eSTAR

    Prepare 510(k) and De Novo submissions in the current eSTAR template, which FDA lists as mandatory unless exempted. Explain in the submission how you addressed each point of the Pre-Sub feedback, and plan who will answer additional-information requests and how fast.

COMMON PITFALLS
  • !Choosing a predicate with a different intended use because its technology is similar.
  • !Testing before the Pre-Sub and discovering FDA expected another method.
  • !Letting an additional-information request on a De Novo pass 180 days, which treats the request as withdrawn.
  • !Describing a cleared device as “FDA approved”, which 807.97 treats as misbranding.
REGULATORY BASIS
GO DEEPER

How to Choose a US Device Premarket Pathway: frequently asked questions

Common questions on choose a us device premarket pathway.

Can we go straight to De Novo without a 510(k) first?

Yes. Section 860.200(b) allows a De Novo request after a not-substantially-equivalent decision, or directly when the sponsor determines there is no legally marketed device on which to base substantial equivalence.

How many questions should a Pre-Submission ask?

FDA’s May 2025 Q-Submission guidance says it has found it difficult to address more than 3–4 substantial topics in one Pre-Sub and recommends no more than 7–10 questions, including sub-questions, across no more than four topics.

Is eSTAR required for a PMA?

No. FDA lists eSTAR as voluntary for original PMAs and PMA supplements, and mandatory, unless exempted, for 510(k) and De Novo submissions.

RELATED HOW-TO GUIDES
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WHERE NEXT

  1. DO ITOpen the Q-Submission (Pre-Sub) Request template →The structure these steps fill in.
  2. UNDERSTAND ITUS Device Premarket Pathways: 510(k), De Novo and PMA →The principles behind the procedure.
  3. ALL GUIDESBrowse all 127 how-to guides →

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