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.
April 2, 2025
Approximately 5 minutes
How Long is the FDA Review Process for 510(k) Medical Device Submissions? (MDUFA III Goals)
FDA 510(k) Review Timeline: MDUFA III Performance Goals
The US Food and Drug Administration (FDA) provides a clear communication timeline for the review of 510(k) Premarket Notifications to establish predictability and transparency for medical device manufacturers. This timeline is structured according to the performance goals set forth by the Medical Device User Fee Amendments of 2012 (MDUFA III).
🗓️ Key Review Milestones
The FDA's goal is to issue a final clearance decision for most 510(k) applications within 90 calendar days. The process is broken down into the following key communication stages:
| Review Stage | Timeframe (Calendar Days) | FDA Action / Outcome |
|---|---|---|
| Acceptance Review | Within 15 days | Initial decision on whether the submission is complete and accepted for substantive review. |
| Substantive Review | Within 60 days | Initial decision on whether the submission meets the requirements for clearance, often leading to an initial communication of deficiencies or questions. |
| Final Decision | Within 90 days | Issuance of the final clearance or denial decision. |
| Notification of Issues | Within 100 days | Applicants with outstanding review issues or who require additional information (AI) from the FDA will be officially notified. |
The MDUFA III goals and the corresponding communication chart were established partly in response to industry concerns regarding unpredictable and inconsistent requests for additional information, which had often caused significant registration delays.
While this chart outlines the FDA’s performance goals for the review process, the actual duration can still vary based on the complexity of the device and the time taken by the manufacturer to respond to any Requests for Additional Information (AI). A timely and complete response is crucial for achieving clearance within the 90-day goal.
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 Clearance Pathways: Classification, QSR, and the 510(k) / PMA Process
All medical and IVD devices for sale in the US must follow the FDA's regulatory process, which involves risk-based classification (Class I, II, III), compliance with the Quality System Regulation (QSR), and securing premarket authorization through 510(k) or Premarket Approval (PMA).
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
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.