US FDA Medical Device Registration, 510(k) & US Agent

US Medical Device Registration Overview: This page covers the regulatory authority, device classification, registration process, local agent requirements and FAQs for medical device registration in the United States. Medical devices in the US are regulated by the FDA’s Center for Devices and Radiological Health (CDRH), and EVERBIZ can support you through the entire process from classification to clearance.

1. Regulatory Framework

Medical devices in the US are regulated by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). The US is the world’s largest, most mature and most influential medical device market, and many other countries use FDA approval as a basis for expedited review.

Core legislation:

Federal Food, Drug, and Cosmetic Act (FD&C Act) – the principal statute
21 CFR Parts 800–1299 – medical device regulations (key parts include 800, 803, 806, 807, 820 and 830)
MDUFA V (Medical Device User Fee Amendments passed in 2022, covering FY2023–2027)

Submissions are made via the CDRH Customer Collaboration Portal (CDRH Portal) using the eSTAR electronic template.

2. Risk Classification

The FDA uses a three-tier risk classification:

Class	Risk	Regulatory controls	Typical pathway	Examples
Class I	Low	General controls	Mostly exempt; registration + listing only	Examination gloves, tongue depressors, bandages
Class II	Moderate	General + special controls	510(k)	Infusion pumps, X-ray systems, condoms
Class III	High	General controls + premarket approval	PMA	Pacemakers, implantable defibrillators, artificial heart valves

The FDA has classified about 1,700 generic device types across 16 medical specialty panels. About 99% of devices are Class I or Class II (“moderate risk”).

3. Four Main Pathways to Market

1. 510(k) Premarket Notification

Applies to: Class II and a small number of Class I/III devices

Core requirement: Demonstrate Substantial Equivalence (SE) to a legally marketed “predicate device” –

Same intended use, or
Different technological characteristics that do not raise new questions of safety and effectiveness

Subtypes: Traditional, Abbreviated (based on recognized standards), Special (for minor modifications to the manufacturer’s own device)

FDA review goal (MDUFA V): 95% within 90 FDA days (FY2025–2027). Actual end-to-end time: typically 6–9 months (including interaction with the FDA)

2. De Novo Classification Request

Applies to: novel low-to-moderate risk devices with no legally marketed predicate

Mechanism: Avoids automatic Class III designation requiring a PMA. A De Novo grant creates a new Class I/II classification, so future similar products can use the 510(k) pathway.

Important change: From 1 October 2025, all De Novo requests must be submitted using the eSTAR electronic template.

FDA review goal: 70% within 150 FDA days (FY2025–2027)

3. PMA (Premarket Approval)

Applies to: Class III high-risk devices – the most stringent and comprehensive FDA approval pathway

Core requirements:

Sufficient valid scientific evidence of safety and effectiveness
Usually includes a pivotal clinical trial
Detailed design, manufacturing and QMS information
May require review by an Advisory Panel

Review time: 180 statutory days plus interaction time; average total time in FY2025–2027 about 285 days

4. HDE / HUD (Humanitarian Device Exemption)

Applies to: devices for rare diseases (affecting ≤8,000 people per year). A simplified alternative to PMA requiring evidence of “probable benefit” rather than effectiveness.

5. Breakthrough Devices Program

For innovative devices treating serious or life-threatening conditions, offering priority review + expedited communication. More than 100 breakthrough devices had been authorized as of 2025.

4. Requirements for All Manufacturers: Registration & Listing

Whatever the pathway, all manufacturers, initial importers, reprocessors, etc. must complete the following every year:

1. Establishment Registration

Register the establishment in the FDA system
Foreign manufacturers must designate a U.S. Agent

2. Device Listing

List the proprietary name, product code, regulatory status and activities at each establishment

3. Pay the annual fee – FY2026 (1 October 2025 – 30 September 2026): USD 11,423

Key deadlines:

Registration window: 1 October – 31 December each year

Missing it means the establishment is no longer “legally registered”, new submissions are put on hold, and imported products are considered “misbranded”

5. FY2026 User Fees (USD)

Application type	Standard fee	Small business fee
Establishment registration (annual)	$11,423	No reduction
510(k)	$25,072	$6,517
513(g) (request for information)	$7,522	$3,761
De Novo	$167,140	$41,785
PMA / PDP / PMR / BLA	$556,758	$139,190
Panel-track supplement	$417,569	$104,392
180-day supplement	$83,514	$20,879
30-Day Notice	$8,908	$4,454
Class III annual report	$19,487	$4,872

Small business qualification (SBD Program):

Gross receipts of the company and affiliates ≤ USD 100 M: eligible for reduced fees

Gross receipts ≤ USD 30 M: first PMA / PDP / PMR / BLA fee fully waived

Gross receipts ≤ USD 1 M with demonstrated financial hardship (e.g. bankruptcy): may apply for a registration fee waiver (new in FY2026)

6. A Must for Foreign Manufacturers: the U.S. Agent

Foreign manufacturers must designate a U.S. Agent, whose responsibilities include:

Receiving FDA inspection notices and urgent communications on the manufacturer’s behalf
Helping to arrange FDA inspections
Not taking over the manufacturer’s product compliance responsibilities
Each foreign establishment may designate only one U.S. Agent

The U.S. Agent must be a legal entity or individual located in the US and reachable by the FDA during business hours.

7. Registration Process (510(k) Example)

Step 1 — Product classification: Search the FDA Product Classification Database. If unsure, submit a 513(g) Request (USD 7,522) for official feedback.

Step 2 — Select a predicate device: Find a legally marketed device in the 510(k) database that is substantially equivalent to your product.

Step 3 — Establish a QMS (21 CFR 820, the QSR)

Important update: The FDA has issued the QMSR (amended 21 CFR 820), aligning 21 CFR 820 with ISO 13485:2016
Effective date: 2 February 2026 – FDA QMS inspections will then follow the ISO 13485 framework
A historic alignment of the FDA with the global QMS standard

Step 4 — Testing and verification

Biocompatibility (ISO 10993)
Electrical safety (IEC 60601)
Software (IEC 62304 + cybersecurity)
Sterilization validation
Performance testing

Step 5 — Prepare the 510(k) submission using the eSTAR template, including:

Device description and intended use
Substantial equivalence discussion versus the predicate
Risk management (ISO 14971)
Performance data
Draft labeling
Clinical data (if applicable)

Step 6 — Submit via the CDRH Portal + pay the fee

Step 7 — FDA review

Acceptance review (first 15 days)
Substantive review – you may receive an Additional Information (AI) Request, which must be answered within 180 days

Step 8 — Obtain 510(k) clearance (K number): Once a K number is issued, the device may be legally marketed in the US.

Step 9 — Complete establishment registration and device listing before marketing

8. QMSR Transition: the Key Date of 2 February 2026

The QMSR (Quality Management System Regulation) replaces the current QSR (21 CFR 820). Key changes:

Full alignment with ISO 13485:2016 – no need to maintain two separate systems
Certain FDA-specific requirements are retained (e.g. 21 CFR 803 adverse event reporting, traceability)
Change in inspection approach: FDA investigators will take a perspective similar to that of ISO 13485 auditors

Strategic significance: The compliance threshold for foreign manufacturers already holding ISO 13485 certification to enter the US market is significantly lowered, and MDSAP certification becomes even more valuable.

9. Post-Market Obligations

Medical Device Reporting (MDR) – under 21 CFR 803, manufacturers must report within 30 days (serious injury / death / malfunction), and in certain cases within 5 working days
Corrections and removals reporting – under 21 CFR 806, recalls must be reported in writing within 10 working days
UDI (Unique Device Identification) – phased implementation by risk class has been completed
MDSAP – MDSAP audit reports can replace some routine FDA inspections
Annual report (Class III) – USD 19,487 (FY2026)
Import entry and customs clearance – via the Import Trade Auxiliary Communication System (ITACS)

10. IVDs and Special Product Categories

IVDs:

Most follow the 510(k) or PMA pathway
CLIA Waiver applications – for simple-to-use tests (home use, point of care)
LDTs (laboratory developed tests): the FDA’s April 2024 final rule brings LDTs under device regulation, phased in through 2028

SaMD / AI medical software:

Predetermined Change Control Plans (PCCP) allow pre-authorized model update mechanisms
The AI/ML-Based Software Action Plan continues to guide regulation of AI devices

Combination products:

Coordinated by the Office of Combination Products (OCP)
The lead center (CDRH / CDER / CBER) is determined by the primary mode of action (PMOA)

11. Recent Key Changes (Timeline)

Date	Event
April 2024	FDA final rule brings LDTs under device regulation
31 July 2025	FY2026 user fees published; registration fee rises to USD 11,423 (+23%)
1 October 2025	eSTAR electronic submission mandatory for De Novo requests
1 October 2025	FY2026 user fees take effect
2 February 2026	QMSR replaces QSR, aligned with ISO 13485:2016
FY2025–2027	MDUFA V continues, with review goals for 510(k)/De Novo/PMA
2028	LDT regulation fully implemented

Strategic Value and Challenges

Opportunities:

The world’s largest market – about 40%+ of global medical device sales
The most widely recognized approval – FDA approval underpins expedited pathways in almost every country
The 510(k) pathway is relatively mature and predictable – 95% completed within 90 FDA days
Small business fee reductions – gross receipts ≤ USD 100M can cut fees substantially
MDSAP certification can reduce routine FDA inspections
QMSR aligned with ISO 13485 – reduces global compliance complexity
Breakthrough Devices and PCCP – friendly to innovative devices

Challenges:

Application fees are among the highest in the world (a PMA costs nearly USD 557,000)
Demanding testing and verification requirements
Increasingly rigorous substantial equivalence arguments for 510(k)
Short adverse event reporting deadlines (30 days / 5 working days)
Complex import and customs clearance procedures
Mandatory U.S. Agent, plus time-zone and cultural communication challenges
The new LDT rule brings major changes to the IVD industry
Cybersecurity requirements (Section 524B, 2023) continue to tighten

How EVERBIZ Can Help

EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the US market, we offer:

Product classification and registration pathway planning
Preparation and review of 510(k), De Novo and PMA submissions
Local authorized representative / registration holder arrangements
Submission, responses to deficiency letters and progress tracking
Post-market compliance maintenance (changes, renewals, adverse event reporting)

Contact us for a US medical device registration plan and quote, or see our registration services for other countries and regions.

US Medical Device Registration FAQs

Which agency regulates medical devices in the US?

The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA).

What are the main pathways to the US market?

Depending on risk class, the main pathways are exemption, 510(k) premarket notification, De Novo classification request and PMA premarket approval. Most Class II products follow the 510(k) pathway.

Do foreign manufacturers need a U.S. Agent?

Yes. Foreign manufacturers must designate a U.S. Agent, complete Establishment Registration and Device Listing, and pay the annual registration fee.

When does the QMSR take effect?

The FDA Quality Management System Regulation (QMSR) takes effect on 2 February 2026. Based on ISO 13485:2016, it replaces the former QSR (21 CFR 820).