Usage Examples
- CDRH accepted the 510(k) once the RTA checklist review cleared.
- We are taking the test plan to CDRH as a Q-Submission before we lock the protocol.
- CDRH issued an additional information request, so the review clock is on hold.
What is CDRH (Center for Devices and Radiological Health)?
CDRH is the FDA center that regulates medical devices, in vitro diagnostics, and radiation-emitting electronic products, reviewing premarket submissions such as the 510(k) and enforcing quality-system and adverse-event reporting duties after market entry.
CDRH exists because a medical device cannot be assessed the way a drug is. A device's risk lives in its design, materials, energy output, and software behaviour rather than in a dose-response curve, so the review has to be comparative and engineering-driven. CDRH is the FDA center built for that job, covering the product from premarket submission through postmarket surveillance.
CDRH covers device classification, premarket review including the 510(k) pathway, quality-system requirements under the QMSR, adverse-event reporting, and radiation safety for electronic products. CDRH does not review drugs or biological products, which belong to CDER and CBER. Nor does CDRH authorise anything outside the United States: a clearance is US market access only and confers nothing in the EU, Canada, or Japan.
CDRH is engaged in practice long before a submission is filed. Sponsors use the Q-Submission programme to pressure-test predicate choice and testing strategy, then file the premarket notification at least 90 days ahead of commercial distribution. After clearance, CDRH's relationship with the company becomes a reporting one: 30-day and 5-day adverse-event reports, plus a quality system inspected against Part 820.
Not to be confused with
- CDER
- CDER is FDA's center for drugs. A product regulated as a drug never enters CDRH's premarket pathways, so 510(k) and PMA vocabulary simply does not apply to it.
- CBER
- CBER is FDA's center for biologics. A product licensed under a BLA sits outside CDRH's device pathways even when it is administered by hardware that CDRH does regulate.
- Notified body
- in the EU, conformity assessment is performed by private notified bodies designated by member states. CDRH reviews the submission itself, so there is no US equivalent of selecting your own reviewer.
- QMSR
- QMSR is one regulation CDRH administers, not the organisation. "CDRH compliant" is not a status; compliance is always measured against a named part such as 21 CFR Part 820 or Part 803.
CDRH's obligations attach at different points in the product lifecycle. These are the anchors.
What you must do
- 1Submit a premarket notification to FDA at least 90 days before introducing the device into interstate commerce for commercial distribution, if your establishment is required to register and the device is not exempt21 CFR 807.81(a)
- 2File again before a device already in commercial distribution is significantly changed or modified in design, components, method of manufacture, or intended use21 CFR 807.81(a)(3)
- 3Report to FDA no later than 30 calendar days after the day you receive or otherwise become aware of information, from any source, that reasonably suggests a device you market meets the reporting criteria21 CFR 803.50
- 4Escalate to a 5-day report, filed no later than 5 work days after the day you become aware of an event in the categories designated for 5-day reporting21 CFR 803.53
- 5Operate a quality management system meeting the QMSR, which incorporates ISO 13485:2016 by reference and became effective on 2 February 202621 CFR Part 820
Common mistakes
Shipping a modified device on the original clearance
the change trigger is written broadly: design, components, method of manufacture, or intended use. Teams treat a supplier swap or a manufacturing change as internal, then find the device is being distributed without a valid premarket notification, which is an adulteration and misbranding exposure, not a paperwork gap.
Starting the 30-day MDR clock at internal confirmation
the regulation runs from the day you receive or otherwise become aware of information from any source. A complaint sitting in a distributor's inbox or a field engineer's email has already started the clock, so investigations that "pause" it produce late reports on their face.
Maintaining a quality system against the old QSR text
the QMSR became effective on 2 February 2026 and incorporates ISO 13485:2016 by reference. Procedures still mapped clause-by-clause to the previous Quality System Regulation structure no longer line up with what CDRH inspects against.
When This Matters
- CDRH accepted the 510(k) once the RTA checklist review cleared.
- We are taking the test plan to CDRH as a Q-Submission before we lock the protocol.
- CDRH issued an additional information request, so the review clock is on hold.
Frequently Asked Questions
At least 90 days before you introduce the device into commercial distribution, if you are required to register your establishment and the device is not exempt. A second trigger applies to devices already on the market: file again before the device is significantly changed in design, components, method of manufacture, or intended use.
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