Your Regulatory Partner for U.S.- FDA Medical Device Approval
The United States maintains one of the most comprehensive and rigorously enforced frameworks for medical device regulation USA. Overseen by the Center for Devices and Radiological Health (CDRH) under the U.S. Food and Drug Administration (FDA), this system defines classification pathways, premarket submissions, and post-market obligations with exceptional clarity. With decades of regulatory evolution since the Medical Device Amendments of 1976, the FDA framework continues to set global benchmarks for safety, efficacy, and quality assurance. DDReg supports medical devices manufacturers in navigating these pathways with precision, from identifying the correct device classification to preparing compliant 510(k), De Novo, or PMA submissions. Our medical devices regulatory experts ensure that each step aligns seamlessly with FDA expectations, enabling timely FDA medical devices registration, audit readiness, and sustainable market access.
U.S. FDA Medical Device Registration & Listing Framework
| Parameter | Technical Detail |
|---|---|
| Governing Regulation | 21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
| Responsible Authority | U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) |
| Who Must Register | Domestic and foreign manufacturers, specification developers, contract sterilizers, repackers, relabelers, initial importers, and distributors of medical devices in U.S. commerce |
| Registration Type | Annual establishment registration (renewal required each fiscal year by December 31) |
| Device Listing | Mandatory listing of every device intended for U.S. distribution, with product code, device name, and relevant regulation number |
| Associated Submissions | 510(k), De Novo, PMA, HDE, or EUA, depending on classification and intended use |
| U.S. Agent Requirement | Mandatory for all foreign manufacturers and initial importers to maintain FDA correspondence |
| Post-Registration Obligations | Maintenance of accurate establishment and device data; updates within 30 days of changes; renewal annually; compliance with FDA inspections |
| Database Access | FDA Establishment Registration & Device Listing database (publicly searchable) |
| Regulatory Objective | Enables FDA oversight of manufacturing and distribution networks for traceability, compliance verification, and rapid response in public health events |
US FDA Medical Device Classification
The FDA classifies medical devices into three categories based on the level of control required to ensure safety and performance:
- Class I (Low Risk): Subject to general controls. Many are exempt from premarket submission but must comply with FDA medical device registration, listing, and quality system regulations.
- Class II (Moderate Risk): Require general and special controls. Most devices in this category need 510(k) clearance prior to marketing.
- Class III (High Risk): Require Premarket Approval (PMA) and extensive clinical evidence demonstrating safety and effectiveness.
Correct classification determines not only the premarket submission type but also the device listing details, regulatory obligations, and review timelines. DDReg conducts comprehensive classification assessments to ensure that your medical device’s FDA submission and listing strategies align with FDA’s expectations from the outset.
Our End-to-End Regulatory Services for US Medical Device Market Access
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Regulatory Footprint & Pathway Strategy
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Medical Devices Establishment Registration & Device Listing Support
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Premarket Submission Services
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Post-Market and Lifecycle Compliance
Why choose DDReg as Your Trusted Regulatory Partner for Medical Device Registration USA?
DDReg brings deep, specialist expertise in U.S. medical device regulation, delivering more than just advisory input, we provide actionable, end-to-end regulatory affairs service execution. Our strategy is customized to your device classification, business model, and commercial objectives, enabling efficient medical devices regulatory strategy , FDA submissions and sustainable market success. With a strong track record of assisting non-U.S. manufacturers entering the U.S. market, DDReg ensures complete regulatory alignment through a hybrid regulatory-commercial approach that balances time-to-market, cost optimization, and long-term risk management.