United States Medical Device Registration

United States Medical Device Registration (FDA – CDRH)

1. Regulatory Authority & Framework

Medical devices in the U.S. are regulated by:

FD&C Act (Federal Food, Drug, and Cosmetic Act)
21 CFR Parts 800–898
FDA CDRH – Center for Devices and Radiological Health
Quality System Regulation (QSR) – 21 CFR 820 (will transition to QMSR, ISO 13485-based, in 2026)
UDI regulation, PMS regulations, inspection programs

The U.S. FDA is one of the world’s most rigorous and influential regulatory systems.

2. Device Classification (Class I / II / III)

Unlike other markets, the U.S. uses three classes, based on risk AND regulatory control levels.

Class	Risk Level	Pathway Examples
Class I	Low	Most exempt; often require registration & listing only
Class II	Moderate	510(k) required (majority of devices)
Class III	High	PMA required (life-supporting/sustaining devices)

Example Categories:

Class I: manual instruments, bandages, non-powered devices
Class II: suction pumps, blood glucose meters, HF surgical devices
Class III: implantables, robotic surgical systems, life-support devices

3. Key U.S. FDA Registration Pathways

3.1 510(k) Premarket Notification (Class II)

Most common pathway (~90% of registrations).
Device must demonstrate substantial equivalence to a predicate device.

Types of 510(k):

Traditional 510(k)
Special 510(k) (for modifications within same company)
Abbreviated 510(k) (standards-based)

Timeline: 90 FDA days → typically 4–6 months total
Validity: No expiry, but device & facility must maintain compliance.

3.2 De Novo Classification (for novel low/moderate risk devices)

Used when the device has no predicate and risk is not high enough for PMA.

Used for AI/ML, innovative software, AR/MR devices
Creates a new product code + regulation number
After clearance, others can use it as predicate via 510(k)

Timeline: 6–12 months

3.3 PMA – Premarket Approval (Class III)

Most rigorous pathway.

Required for:

Implantables
Life-sustaining devices
High-risk, novel technologies (e.g., surgical robots)

Requires:

Full design dossier
Clinical trials in the U.S. (IDE pathway)
Manufacturing inspection
Biocompatibility, V&V, software, cybersecurity, etc.

Timeline: 1–2+ years
Validity: Annual reporting + strict PMS.

3.4 Exemptions & Special Pathways

Many Class I and some Class II devices are exempt from 510(k)
Breakthrough Device Program
Safer Technologies Program (STeP)
Emergency Use Authorization (EUA) (special cases)

4. Establishment Registration & Device Listing

All manufacturers, specification developers, and initial importers must complete:

Annual FDA Establishment Registration (renewed every year)
Device Listing (what products you market)

Foreign manufacturers must appoint:

U.S. Agent (regulatory liaison)
Initial Importer (if needed)

5. Quality System Requirements

Manufacturers must comply with:

5.1 Current QSR (21 CFR Part 820)

Covers:

Design Controls
CAPA
Production & process controls
Purchasing controls
Complaint handling
Document control

5.2 Transition to QMSR (ISO 13485-based) in 2026

The U.S. will harmonize with ISO 13485, reducing global duplication.

6. Dossier Requirements (510(k) / De Novo / PMA)

510(k) Technical File

Device description
Predicate comparison
Performance testing
Biocompatibility (ISO 10993)
Electrical safety & EMC (IEC 60601)
Software documentation (IEC 62304 + cybersecurity)
Sterilization & packaging validation
Usability engineering (IEC 62366-1)
Labeling

De Novo File

Risk-benefit analysis
Clinical evidence (if required)
Special controls development

PMA File

Full design history file
U.S. clinical data
Manufacturing validation
Extensive V&V
Facility inspection

7. Fees & Timelines

FDA User Fees (FY2025 typical estimates)

510(k): ~$22,000 (small business ~$5,500)
De Novo: ~$130,000 (small business ~$32,000)
PMA: ~$443,000 (small business ~$110,000)
Annual Establishment Registration: $7,653

FDA Review Timelines

510(k): 90 FDA days (4–6 months total)
De Novo: 6–12 months
PMA: 1–2 years
Breakthrough devices: expedited review

8. Labeling Requirements

Labeling must comply with:

21 CFR Part 801
UDI requirements (GS1/UDI database: GUDID)
English language (supplemental languages allowed)

Content:

Device name/model
Indications for use
Contraindications, warnings
Sterilization/expiry
Manufacturer details
UDI barcode

9. Post-Market Surveillance