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
US FDA Medical Device & IVD Registration
All companies planning to sell a medical device or IVD in the United States need to register their product with the US FDA.
✅ Class II
✅ Class III
✅ IVD Devices
⚠️ Key Requirement: Most Class I devices can be self-registered, but most Class II devices require a 510(k) submission. For Class III devices, a Pre-Market Approval (PMA) submission is needed.
The US FDA Medical Device & IVD Approval Process Explained
The steps below provide a brief overview of how the PMA and the FDA 510(k) process work. The chart shown illustrates the FDA approval process in the USA and is available for download in PDF format.
RABT has exclusive delivery centers in the U.S. and EU, with a professional team providing regulatory support to manufacturers in maintaining the quality and safety needed for approval.
RABT’s intelligence experts keenly observe regulatory updates and keep clients informed about the steps to be taken for product compliance with current standards.
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
Determine the classification of your medical device or IVD by searching the FDA classification database, or by identifying a predicate device with the same intended use and technology. Note the three-letter Product Code and seven-digit Regulation Number. If unclear, use the 513(g) process to request classification from the FDA.
Class I / II / III
Implement a Quality Management System
Some Class I devices are exempt from most QSR requirements, with exceptions. For Class II and III devices, implement a Quality Management System (QMS) that meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820.
QMS / QSR
Get Pre-Submission (Pre-Sub) Feedback
Innovative Class II and all Class III devices will likely require clinical studies. Get “Pre-Submission (Pre-Sub)” feedback from the FDA before proceeding.
Recommended
Conduct Clinical Studies
If clinical studies are required, apply for an Investigational Device Exemption (IDE). Develop a clinical trial protocol and conduct the study. Non-significant risk studies may be performed with IRB approval.
IDE / IRB
Prepare & Submit 510(k) or PMA Application
For Class II devices, prepare and submit a 510(k) Premarket Notification application and pay the related fee. For Class III devices, prepare and submit a Premarket Approval (PMA) application and pay the PMA submission fee.
510(k) / PMA
FDA Facility Inspections
For Class III devices, the FDA conducts facility inspections of the manufacturer and all major suppliers involved in the design and production of the device. All parties must be compliant with FDA QSR.
Class III Required
Receive PMA Approval
For Class III devices, the FDA issues a PMA approval letter and posts it online.
Class III
Comply with Ongoing FDA Regulations
The FDA may conduct random inspections and can issue a Form 483 for non-compliance.
Post-Market
Designate a U.S. Agent
Your U.S. Agent serves as the primary point of contact with the FDA on your company’s behalf.
U.S. Agent
Establishment Registration & Listing
Complete Establishment Registration and Listing, which must be renewed each year.
Annual Renewal
Begin Selling in the US
You are now able to sell your device in the US. Your company and device registration status will be listed on the FDA website. Your authorization does not expire as long as no changes are made to the device design, intended use, etc.
Market Ready
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 and Risk Assessment document preparation.
513(g) Support
Device classification request support when the product code cannot be determined.
510(k) Registration
Device registration support through the FDA 510(k) Premarket Notification pathway.
De-Novo Request for Classification
Device registration support through the De-Novo Classification request pathway.
PMA Registration
Device registration support through the FDA Premarket Approval (PMA) pathway.
QMS Support
Quality Management System support for 21 CFR 820 or MDSAP compliance.
Labeling Support
FDA-compliant labeling review and development support.
Publishing & Submission Support
Regulatory consultancy services for addressing deficiencies raised during 510(k) application review.
Publishing Support
Preparation and formatting support for regulatory submission publishing.
U.S. Agent
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.
Commercialization Support
Distributor identification and qualification for compliance with U.S. requirements.
Small Business Certification
Support in obtaining FDA Small Business Certification for reduced submission fees.
Establishment Registration
Annual FDA establishment registration and comprehensive device listing management.
Device Listing
FDA device listing management and maintenance.
Radiation Device Accession
Compilation of product reports and obtaining device accession numbers for radiation-emitting devices.
Post Approval Change Management
Major and minor change notifications including design changes and new indications.
Post Market Surveillance
Post-market obligations and ongoing surveillance support.
UDI Compliance
Unique Device Identification (UDI) system compliance support.
NIOSH Certification
Support for NIOSH certification requirements for applicable respiratory protective devices.