How medical devices are regulated in the US

In the United States, medical devices are regulated by FDA’s Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act. The detailed rules sit in Title 21 of the Code of Federal Regulations, Parts 800 to 898. The system is risk-based: the higher a device’s risk, the more evidence FDA needs before it can be sold and the more controls apply afterward.

The volume is large. In 2025, CDRH received 21,780 submissions, according to MedTech Dive’s review of FDA’s annual report (MedTech Dive). Emergo by UL counted 3,238 510(k) clearances, 27 De Novo grants and 41 PMA approvals that year, and FDA reported that “124 authorizations in 2025 were for novel medical devices” (Emergo by UL).

Step 1: Device classification

FDA has classified roughly 1,700 generic device types, grouped into 16 medical specialty panels (FDA). Each type is assigned to one of three classes:

ClassRiskTypical controlsExamples
Class ILowGeneral controls; most are exempt from 510(k)Tongue depressors, elastic bandages
Class IIModerateGeneral and special controls; usually 510(k)Powered wheelchairs, infusion pumps, many software functions
Class IIIHighGeneral controls and premarket approvalImplantable pacemakers, heart valves

FDA notes that “Approximately 572 or 74% of the Class I devices are exempt” from premarket notification (FDA). To classify your device, search FDA’s product classification database for a similar device, then confirm the regulation number and product code.

Step 2: Choosing the premarket pathway

FDA describes its main marketing pathways on its Device Approvals and Clearances page, calling PMA “the most stringent type of device marketing application” (FDA).

PathwayWhen it appliesStandardFY2027 fee (standard / small business)
510(k)Device is substantially equivalent to a legally marketed predicateSubstantial equivalence$28,653 / $7,163
De NovoNovel low- to moderate-risk device with no predicateReasonable assurance of safety and effectiveness with general/special controls$191,020 / $47,755
PMAClass III devicesValid scientific evidence of safety and effectiveness, usually clinical data$636,732 / $159,183
HDEDevices for rare conditions (Humanitarian Use Devices)Probable benefit outweighs riskExempt from most fees

Fee figures come from FDA’s FY2027 user fee notice (Federal Register). Submissions for 510(k) and De Novo must use FDA’s eSTAR template, mandatory since October 1, 2023 and October 1, 2025 respectively, and can be sent through the CDRH Portal (FDA).

Step 3: The regulations that apply after clearance

Market authorization is the start of regulatory obligations, not the end. These are the 21 CFR parts most device makers work with every day:

21 CFR partTopic
801Labeling
803Medical device reporting (adverse events)
806Reports of corrections and removals
807Establishment registration, device listing, 510(k)
812Investigational device exemptions (clinical studies)
814Premarket approval
820Quality Management System Regulation (QMSR)
821Device tracking
830Unique device identification

FDA’s overview groups these into its basic regulatory requirements: registration, listing, premarket notification or approval, IDE, the quality system, labeling and medical device reporting (FDA).

What changed in medical device regulations in 2025–2026

  • QMSR replaced the QSR. Since February 2, 2026, Part 820 incorporates ISO 13485:2016 by reference, with FDA-specific requirements for complaints, servicing, labeling and records (FDA).
  • A new inspection program. CP 7382.850 organizes inspections into six QMS areas (FDA).
  • Software and AI guidance. FDA updated its Computer Software Assurance guidance on February 3, 2026 (FDA), finalized its predetermined change control plan guidance for AI-enabled devices (FDA), and revised its clinical decision support and general wellness guidances in January 2026 (Arnold & Porter).
  • Higher fees and a new MDUFA cycle. FY2027 fees took effect October 1, 2026, and MDUFA VI must be reauthorized by September 30, 2027 (RAPS). Exponent reports that the draft agreement proposes a $2,000 fee for pre-submissions (Exponent).
  • Fewer reviewers. CDRH says it is meeting review goals, but guidance output fell from 38 documents to 21 in 2025 (MedTech Dive). Expect less informal help and plan for well-prepared pre-submissions.

Medical device regulations outside the US

MarketRegulator / framework2026 status
European UnionMDR (EU) 2017/745 and IVDR; notified bodies issue CE certificatesEUDAMED modules mandatory since May 28, 2026 (HPRA); legacy transition to Dec 31, 2027 / Dec 31, 2028; reform adoption targeted for mid-2027 (Emergo)
EU (AI)AI ActHigh-risk rules for AI in regulated products, including medical devices, moved to Aug 2, 2028 by Regulation (EU) 2026/1744 (Gibson Dunn)
Canada, Brazil, Japan, Australia, USMDSAP single auditOne audit of the QMS can satisfy multiple regulators (FDA)

Quick reference: which regulations apply to you?

If you…Start with
Are developing a new deviceClassification (Part 860 regulations), design controls under QMSR, ISO 14971
Are ready to submit510(k) (Part 807 Subpart E), De Novo or PMA (Part 814); eSTAR
Make or relabel finished devicesRegistration and listing (Part 807), QMSR (Part 820), labeling (Part 801), UDI (Part 830)
Have devices on the marketMDR (Part 803), corrections and removals (Part 806), tracking (Part 821)
Sell in EuropeMDR Annexes I, II, III, IX–XI; EUDAMED
Build AI or software devicesSoftware premarket guidance, PCCP guidance, CDS guidance; EU AI Act

Map regulations to your documents

Knowing which regulations apply is half the job. The other half is proving that your procedures, design files and submissions meet them. AI document assessment can check documents against QMSR, ISO 13485 or the EU MDR clause by clause and cite the passage behind every finding.

Run a sample regulatory document assessment on one procedure or submission section. AskDona shows the evidence; your team decides.

FAQ

Who regulates medical devices in the US? FDA’s Center for Devices and Radiological Health (CDRH), under the Federal Food, Drug, and Cosmetic Act and 21 CFR Parts 800–898.

What is the difference between 510(k), De Novo and PMA? 510(k) shows substantial equivalence to an existing device; De Novo creates a new classification for a novel low- or moderate-risk device; PMA is required for most Class III devices and is the most demanding pathway (FDA).

How do I know my device’s class? Search FDA’s product classification database for a similar device type and confirm the regulation number and product code (FDA).

How much does a 510(k) cost in 2026? The FY2027 fee, in effect from October 1, 2026, is $28,653, or $7,163 for qualifying small businesses (Federal Register).

References

All pages opened and checked by October 13, 2026.

SourceTypeDateUsed for
FDA: Classify Your Medical DeviceRegulatorCurrentClasses, exemptions
FDA: Device Approvals and ClearancesRegulatorCurrentPathways
FDA: Overview of Device RegulationRegulatorCurrentBasic requirements
FDA: QS Regulation / QMSRRegulator2026QMSR
FDA: CP 7382.850RegulatorFeb 2, 2026Inspection areas
FDA: CDRH PortalRegulatorCurrenteSTAR
FDA: CSA guidanceRegulator guidanceFeb 3, 2026Software assurance
FDA: PCCP guidance for AIRegulator guidanceFinalAI changes
FDA: MDSAPRegulatorCurrentSingle audit
Federal Register: FY2027 user feesRegulator2026Fees
Emergo by UL: FDA 2025 annual reportConsultancyFeb 4, 2026Authorization counts
MedTech Dive: CDRH on trackTrade pressJan 29, 2026Submissions, guidances
RAPS: MDUFA VI draftProfessional bodyJul 8, 2026MDUFA VI
Exponent: Draft MDUFA VIConsultancyAug 14, 2026Pre-sub fee
Arnold & Porter: CDS guidanceLaw firmJan 21, 2026CDS, wellness
HPRA: EUDAMEDRegulator (EU)2026EUDAMED
Emergo by UL: MDR/IVDR revisionConsultancyOct 9, 2026EU reform
Gibson Dunn: AI Act OmnibusLaw firm2026AI Act dates