US FDA Medical Device Registration & Consulting Services
NexorTest provides end-to-end US FDA regulatory consulting for medical device and IVD Devices manufacturers — covering 510(k) clearance, PMA approval, De Novo classification, SaMD submissions, and establishment registration. From regulatory design and accredited testing to submission management and post-market compliance, we are your single-window partner for FDA market entry.
Choose the Right FDA Pathway for Your Medical Device
Understanding the three primary FDA regulatory pathways is critical to your market entry strategy. We guide you through each option based on your device's risk classification and predicate availability.
FDA 510(k) Premarket Notification
The FDA 510(k) pathway requires manufacturers to demonstrate that their medical device is substantially equivalent to a legally marketed predicate device. It applies to most Class II and some Class I devices. The FDA typically reviews 510(k) submissions within 90 days of acceptance. NexorTest manages the entire process from predicate selection through clearance. Lowest-risk devices including tongue depressors, bandages, examination gloves, and reusable surgical instruments. Non-sterile, non-measuring Class A devices can be self-notified.
- ~90-Day Review
- Class I & II
- Moderate Risk
FDA PMA — Premarket Approval
PMA is the FDA’s most rigorous review pathway, required for Class III high-risk medical devices. It demands clinical trial data demonstrating safety and efficacy, with a review period of 180+ days. NexorTest provides end-to-end PMA support including clinical strategy, testing coordination, and submission management for complex devices.
- 180+ Day Review
- Class III
- High Risk
FDA De Novo Classification
The De Novo pathway is designed for novel medical devices that are low-to-moderate risk but lack a legally marketed predicate. Once granted, your device becomes a predicate for future 510(k) submissions. Approximately 80% of De Novo requests include clinical studies. Ideal for innovative IVDs and SaMD products entering the US market.
- ~150-Day Review
- Novel Devices
- Low-Moderate Risk
End-to-End FDA Regulatory Consulting
Unlike consultants who only advise, NexorTest supports you from initial regulatory design through accredited testing, documentation, submission, and post-market compliance — a true one-stop FDA solution.
FDA 510(k) Submission Management
Complete 510(k) preparation including predicate research, substantial equivalence arguments, performance testing coordination, eSTAR submission, and FDA correspondence management.
PMA & De Novo Applications
Strategic support for Class III PMA submissions and novel device De Novo classifications, including clinical evidence strategy, panel preparation, and advisory committee support.
SaMD & AI/ML Device Consulting
Specialized regulatory strategy for Software as Medical Device including IMDRF classification, cybersecurity documentation per FDA guidance, software validation, and predetermined change control plans.
FDA Establishment Registration & Device Listing
Annual FDA establishment registration via FURLS, device listing with correct product codes, NDC numbers, and ongoing compliance monitoring for domestic and foreign facilities.
US Agent Services
Designated US Agent for foreign manufacturers as required by FDA. We serve as your official point of contact, manage FDA communications, and ensure uninterrupted compliance.
QMSR / 21 CFR 820 Compliance
Transition support from legacy 21 CFR 820 to the new QMSR framework incorporating ISO 13485:2016. Gap analysis, QMS implementation, and audit preparation for FDA inspections.
Design Verification & Validation Testing
ISO/IEC 17025 accredited EMC/EMI, electrical safety (IEC 60601), biocompatibility, environmental testing, and performance validation at our in-house laboratories.
Clinical Evidence & Strategy
Clinical evaluation strategy, literature review, clinical investigation planning.
Post-Market Surveillance & MDSAP
Ongoing FDA compliance including MDR/eMDR reporting, complaint handling systems, CAPA management, recall strategy, and MDSAP audit preparation across all participating countries.
Why Medical Device Manufacturers Choose NexorTest for FDA Consulting
Most regulatory consultants only advise. NexorTest delivers a fully integrated service — from regulatory strategy and product design through accredited testing to FDA submission — under one roof.
Multi-Region Expertise From a Single Partner
Get simultaneous FDA + CE + CDSCO + SFDA + TGA clearances. One regulatory strategy covering 30 regions without managing multiple consultants.
Design + Testing + Certification Under One Roof
Eliminate vendor fragmentation. Our ISO/IEC 17025 accredited labs and regulatory team work together, reducing timeline by 30–40%.
India-Manufacturer FDA Specialists
Deep expertise helping Indian medical device and IVD companies navigate FDA requirements, US Agent designation, and FURLS registration.
SaMD & IVD Focused Capabilities
Specialized in the fastest-growing device segments — Software as Medical Device and In Vitro Diagnostics — across all major regulatory frameworks.
Transparent Pricing & Fixed-Fee Packages
No hidden costs. Clear, upfront pricing for every service — from 510(k) consultation to complete submission packages. Built for SMEs and startups.
How We Get Your Medical Device FDA-Cleared
A proven 6-step methodology that has successfully delivered 10+ device clearances across all FDA pathways.
Device Classification & Pathway Selection
We determine your device’s FDA class (I, II, or III) and identify the optimal regulatory pathway — 510(k), PMA, or De Novo — based on risk profile and predicate availability.
Predicate Research & Gap Analysis
Comprehensive predicate device analysis, FDA guidance review, gap assessment against applicable standards, and a complete regulatory strategy roadmap.
Design Verification & Validation Testing
EMC/EMI, electrical safety, biocompatibility, environmental, and performance testing at our ISO/IEC 17025 accredited laboratories — all coordinated in-house.
Documentation & Submission Preparation
Complete submission package — device description, substantial equivalence comparison, performance data, labeling, software documentation, and sterilization validation.
FDA Submission & Review Management
eSTAR submission via FDA portal, additional information request management, deficiency letter responses, and interactive review navigation until clearance.
Clearance, Registration & Market Entry
Post-clearance establishment registration, FURLS device listing, US Agent setup, labeling compliance, and ongoing post-market surveillance support.
FDA Regulatory Expertise Across Device Sectors
Our team has cleared devices across every major medical technology category.
- 🏥 Cardiovascular Devices
- 🦴 Orthopedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
FDA Medical Device Registration
Clear, authoritative answers to the most common FDA regulatory questions from medical device manufacturers.
What is an FDA 510(k) submission?
An FDA 510(k) is a premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. Required for most Class II and some Class I devices, it typically takes 90 days for FDA review after acceptance. The submission must include device description, predicate comparison, performance testing data, labeling, and biocompatibility information. NexorTest manages the entire 510(k) process from predicate selection through FDA clearance.
What is the difference between 510(k) and PMA?
A 510(k) demonstrates substantial equivalence to a predicate device and applies to Class II devices, with approximately 90-day review. PMA (Premarket Approval) is required for Class III high-risk devices, demands clinical trial data proving safety and efficacy, and takes 180+ days for review. The De Novo pathway serves novel low-to-moderate risk devices without predicates. NexorTest helps determine the optimal pathway for your specific device.
Do I need a US Agent for FDA device registration?
Yes. Every foreign manufacturer exporting medical devices to the US must designate a US Agent who serves as the FDA’s official point of contact. The US Agent must reside or maintain a place of business in the United States, be available to respond to FDA during business hours, and facilitate communications. NexorTest provides US Agent services along with full FDA establishment registration and device listing support.
What is QMSR and how does it replace 21 CFR 820?
QMSR (Quality Management System Regulation) is the FDA’s new quality system framework that incorporates ISO 13485:2016, replacing the legacy 21 CFR Part 820. Effective February 2026, manufacturers must align their QMS with ISO 13485 while maintaining certain FDA-specific requirements. This harmonization simplifies compliance for manufacturers already certified to ISO 13485. NexorTest helps companies transition from legacy 820 systems to the new QMSR framework.
How long does FDA 510(k) clearance take?
FDA 510(k) review typically takes 90 days after submission acceptance. However, the total timeline including preparation, testing, and documentation ranges from 6 to 12 months depending on device complexity. Traditional 510(k) submissions generally take longer than Special 510(k) submissions. NexorTest’s integrated design-test-submit approach can reduce this timeline by 30–40% compared to using separate consultants and test labs.
How much does FDA 510(k) submission cost?
FDA 510(k) costs include the FDA user fee (approximately $21,760 for small businesses in FY2026; higher for standard applicants), plus consulting and testing costs ranging from $30,000 to $150,000+ depending on device complexity, required testing, and clinical data needs. NexorTest offers transparent fixed-fee packages covering regulatory strategy, documentation, testing coordination, and submission management — with no hidden charges.
What is the FDA De Novo classification pathway?
The FDA De Novo pathway is a regulatory route for novel medical devices that are low-to-moderate risk but have no legally marketed predicate device. Unlike 510(k) which requires a predicate comparison, De Novo allows manufacturers to request new device classification. Approximately 80% of successful De Novo requests include clinical studies. Once granted, your device becomes a predicate for future 510(k) submissions by others.
Can NexorTest help with SaMD FDA registration?
Yes. NexorTest specializes in Software as a Medical Device (SaMD) regulatory consulting across all FDA pathways — 510(k), De Novo, and PMA. Our SaMD services cover classification using the IMDRF framework, cybersecurity documentation per FDA’s premarket guidance, IEC 62304 software lifecycle compliance, clinical evidence strategy for AI/ML-based devices, and predetermined change control plans for adaptive algorithms.
Ready to Enter the US Market?
Get a free, no-obligation regulatory pathway assessment for your medical device. Our FDA specialists respond within 24 hours.
Accreditations & Certifications
Accredited Labs
QMS Certified
National Accreditation
Bureau of Indian Standards
Recognised Consultant
Expand Beyond India with Multi-Market Access
Leverage NexorTest's global regulatory network to register your medical device in 30+ markets from a single integrated program.
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India CDSCO Registration
CDSCO medical device registration, BIS certification, and SUGAM portal submission.