Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
January 2, 2025
Approximately 5 minutes
US FDA Clearance Pathways: Classification, QSR, and the 510(k) / PMA Process
US FDA Clearance Pathways for Medical Devices and IVDs
The regulatory pathway to market for a medical device or In Vitro Diagnostic (IVD) product in the United States is overseen by the U.S. Food and Drug Administration (FDA). This process is mandatory for all products sold commercially in the U.S.
⚙️ Key Steps for FDA Clearance
1. Device Classification
The first step is to determine the device's classification by searching the FDA classification database. Devices are categorized based on risk:
- Class I (Low Risk): Most devices do not require premarket review.
- Class II (Medium Risk): Require 510(k) Pre-market Notification (demonstrating substantial equivalence to a legally marketed predicate device).
- Class III (High Risk): Require Premarket Approval (PMA) (demonstrating safety and effectiveness).
2. Quality Management System (QMS)
All manufacturers must establish and maintain a quality management system (QMS) compliant with the FDA Quality System Regulation (QSR) (21 CFR 820).
3. Submission (510(k) or PMA)
Based on the classification, manufacturers submit the appropriate premarket application and pay the relevant fee:
- 510(k) Submission: Required for most Class II devices. This application demonstrates that the new device is substantially equivalent to a predicate device.
- PMA Submission: Required for all Class III devices. This is the most stringent review, demanding comprehensive scientific evidence, including clinical data, to prove the device's safety and efficacy.
4. Facility Inspection
For high-risk (PMA) devices, the FDA conducts facility inspections of the manufacturer and all major suppliers to verify compliance with the QSR. The FDA then reviews the application and issues a clearance (510(k) letter) or approval (PMA letter).
5. US Agent and FURLS Registration
Once clearance or approval is obtained, the final mandatory steps for market entry are:
- US Agent Appointment: Foreign manufacturers must appoint a U.S. Agent as their local point of contact with the FDA.
- Establishment Registration & Device Listing (FURLS): Companies must annually register their establishment (facility) and list their approved devices using the FDA Unified Registration and Listing System (FURLS) and pay the relevant annual fees.
Related Articles
Approximately 5 minutes
US FDA Establishment Registration and Device Listing (FURLS) Requirements
Annual **Establishment Registration** and **Device Listing** with the US FDA is mandatory for most facilities involved in manufacturing, importing, or reprocessing devices for the US market. Registration is completed via the online **FURLS** system, and listing is generally required unless the entity is an Initial Importer.
Approximately 5 minutes
US FDA Medical Device Classification: Risk-Based System and Pathways for Novel Devices
The US FDA classifies medical devices into Class I, II, or III based on risk, using a predicate-based system. Most Class II devices require a 510(k), while Class III requires Premarket Approval (PMA). Novel devices lacking a predicate may pursue classification via a 513(g) Request or the De Novo pathway to avoid automatic Class III status.
Approximately 5 minutes
Understanding the FDA Q-Submission (Q-Sub) Process and Pre-Submission Guidance
The FDA's Q-Submission (Q-Sub) process, primarily used as a **Pre-Submission (Pre-Sub)**, allows medical device manufacturers to receive formal, non-mandatory regulatory feedback from FDA experts *before* submitting their 510(k), PMA, or IDE application. This early dialogue is crucial for novel or high-risk devices.
Approximately 5 minutes
How Long is the FDA Review Process for 510(k) Medical Device Submissions? (MDUFA III Goals)
The FDA's goal, per MDUFA III, is to issue a final clearance decision for most 510(k) submissions within **90 calendar days**. Key milestones include acceptance review within 15 days and substantive review decisions within 60 days, providing manufacturers with a predictable communication timeline.
Approximately 5 minutes
US Medical Device Clearance: The Predicate Pathway and FDA's Regulatory Philosophy
The US FDA emphasizes different regulatory barriers than the EU. The **510(k) pathway** often allows clearance based on demonstrating **substantial equivalence** to a predicate device, representing a distinct philosophy focused on comparative safety and effectiveness rather than the continuous, stricter clinical evaluation required by the EU MDR.
Approximately 5 minutes
Technical Overview: The FDA ANDA Process for Generic Drug Approval
The Abbreviated New Drug Application (ANDA) is the FDA pathway (Section 505(j)) for generic drug approval, requiring demonstration of **pharmaceutical equivalence** and **bioequivalence (BE)** to a Reference Listed Drug (RLD). The process involves RLD identification, Q1/Q2 formulation, BE studies, stability testing, and eCTD submission under GDUFA.