Regulatory Support for
Medical Devices in USA
End-to-end FDA registration and compliance expertise for medical device and IVD manufacturers, distributors, and importers seeking US market access.
🔍 FDA Regulatory Pathways
Class II — Substantial Equivalence
Class III — Full Premarket Review
Novel Low-to-Moderate Risk Devices
Annual Oct 1 – Dec 31 Renewal
FDA Medical Device Registration
All medical devices sold in the USA must be registered with the FDA regardless of their classification class.
✅ Class II
✅ Class III
✅ IVD Devices
⚠️ Key Requirement: For companies planning to sell medical or IVD devices in the United States, registering with the US FDA is mandatory — all device classes require registration.
What Is FDA Medical Device Registration?
The United States Food and Drug Administration (FDA) safeguards public health by regulating medical devices and IVD diagnostics. Every manufacturer, distributor, and importer must comply before selling in the US market.
RABT Global provides comprehensive regulatory support to navigate the PMA and FDA 510(k) processes — from initial device classification through establishment registration, facility inspections, and post-approval compliance.
Our specialists guide you through every requirement under 21 CFR Part 820 and beyond, ensuring your device reaches the US market efficiently and compliantly.
Overview of the PMA & FDA 510(k) Process
A structured pathway to US market entry for medical and IVD devices — from classification through post-market compliance.
Determine Device Classification
Search the FDA classification database or identify a predicate device. Note the three-letter Product Code and seven-digit Regulation Number. If unclear, use the 513(g) process.
Class I / II / III
Implement a Quality Management System
Required for most Class II and III devices and some Class I. QMS must meet FDA QSR under 21 CFR Part 820. Some Class I devices are exempt with exceptions.
QMS / QSR
Get Pre-Submission (Pre-Sub) Feedback
Recommended for innovative Class II and all Class III devices. Pre-Sub feedback from FDA reduces risk of delays and rejections during the review process.
Recommended
Conduct Clinical Studies
Necessary for innovative Class II and all Class III devices. Apply for an Investigational Device Exemption (IDE) before clinical trials. Non-significant risk studies proceed with IRB approval.
IDE / IRB
Prepare & Submit 510(k) or PMA Application
The application type depends on device classification. Both require an FDA submission fee. RABT Global prepares submission-ready dossiers to the highest technical standards.
510(k) / PMA
FDA Facility Inspections
For Class III devices, the FDA inspects the manufacturer and all major suppliers. All parties must be fully compliant with FDA QSR before PMA approval is granted.
Class III Required
Receive PMA Approval
For Class III devices, FDA issues a PMA approval letter and posts it publicly online. RABT Global supports deficiency responses throughout the review process.
Class III
Comply with Ongoing FDA Regulations
The FDA may conduct random inspections and issue a Form 483 for non-compliance. RABT Global supports post-approval surveillance and change management.
Post-Market
Establishment Registration & Device Listing
Must be completed and renewed annually between October 1st and December 31st. Your authorization remains valid as long as no changes affect device design or intended use.
Annual Renewal
510(k) vs PMA — Which Pathway Applies?
Understanding the right submission pathway is critical to a successful FDA regulatory strategy.
FDA 510(k) — Premarket Notification
Primarily for Class II devices demonstrating substantial equivalence
Demonstrates substantial equivalence to a legally marketed predicate device
Required for most Class II and some Class I devices
Generally faster review than PMA (~90 days standard)
QMS under 21 CFR Part 820 required for most Class II
Pre-Sub feedback recommended for novel technologies
Submission fee required; small business discounts available
PMA — Premarket Approval
Required for Class III high-risk devices requiring full evidence review
Required for Class III devices posing the highest risk
Requires valid scientific evidence including clinical trials
FDA conducts facility inspections of manufacturer and suppliers
Investigational Device Exemption (IDE) needed for clinical studies
PMA approval letter issued and published publicly by FDA
Post-approval changes require FDA notification or supplement
FDA Regulatory Services We Provide
Comprehensive support across every stage of the US FDA medical device regulatory lifecycle.
Regulatory Due Diligence
Pre-acquisition and pre-submission regulatory assessments for medical device portfolios.
Device Documentation — DHF & Risk Assessment
Design History File preparation and ISO 14971 risk management documentation.
513(g) Classification Support
Request for device classification from FDA when product code cannot be determined.
510(k) Submission & De Novo Request
Full preparation and submission management of 510(k) and De Novo Classification requests.
PMA Registration
End-to-end PMA application preparation, submission, and deficiency response management.
QMS Support — 21 CFR 820 & MDSAP
Quality Management System implementation to meet FDA QSR and MDSAP compliance.
Labeling Support
FDA-compliant labeling review, gap analysis, and development per 21 CFR Part 801.
U.S. Agent Services
Designated US Agent for foreign manufacturers as required by FDA for device listing.
Q-Submission Meetings
Pre-Sub meeting preparation and facilitation with FDA for early regulatory alignment.
Establishment Registration & Device Listing
Annual FDA establishment registration and comprehensive device listing management.
Post Approval Change Management
Major and minor change notifications including design changes and new indications.
Post Market Surveillance & UDI Compliance
Post-market obligations and Unique Device Identification (UDI) system compliance.