Question 1

What is the FDA and why is it important for medical device manufacturers?

Accepted Answer

The U.S. Food and Drug Administration (FDA) is the regulatory authority responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. The FDA's Center for Devices and Radiological Health (CDRH) oversees medical device regulation through premarket review (510(k), PMA, De Novo), quality system requirements (QMSR), post-market surveillance, and enforcement actions. Compliance with FDA regulations is mandatory for any company selling medical devices in the U.S. market.

Question 2

What are the main FDA pathways for medical device approval?

Accepted Answer

510(k) Premarket Notification: For devices substantially equivalent to existing predicate devices (most common pathway, ~3-6 months).PMA (Premarket Approval): For Class III high-risk devices requiring clinical evidence (12-18+ months).De Novo Classification: For novel low-to-moderate risk devices with no predicate (6-12 months).Breakthrough Device Program: Expedited review for devices treating life-threatening conditions.

Question 3

What is the QMSR and when does it become effective?

Accepted Answer

The Quality Management System Regulation (QMSR) is the FDA's modernized quality system requirement that replaces the current QSR (Quality System Regulation). The QMSR aligns with ISO 13485:2016 international standards and becomes effective in 2026. Key changes include enhanced risk management, improved supplier controls, stronger cybersecurity requirements, and better alignment with global standards. Manufacturers should begin transitioning their quality systems now to ensure compliance by the effective date.

Question 4

What are the FDA's UDI (Unique Device Identification) requirements?

Accepted Answer

The FDA requires all medical devices to carry a Unique Device Identifier (UDI) on their label and packaging. The UDI system includes: Device Identifier (DI): Unique to device version/model, Production Identifier (PI): Lot/serial number, expiration date, manufacturing date. Manufacturers must submit UDI information to the Global Unique Device Identification Database (GUDID). UDI requirements are phased by device class, with most devices now required to comply.

Question 5

What is a US Agent and is it required for foreign manufacturers?

Accepted Answer

A US Agent is a person or business entity designated by a foreign manufacturer or initial distributor as their representative in the United States. The US Agent must reside or maintain a place of business in the U.S. and is responsible for communications with the FDA on behalf of the foreign establishment. Key responsibilities: Acting as communication liaison with FDA, assisting with device inspections, responding to FDA inquiries. A US Agent is required for all foreign manufacturers selling devices in the U.S. market.

Question 6

How does the FDA regulate AI and machine learning medical devices?

Accepted Answer

The FDA regulates AI/ML-enabled medical devices as Software as a Medical Device (SaMD) under existing frameworks, with additional considerations for adaptive algorithms. Key guidance includes: Predetermined Change Control Plans: Allow modifications without new 510(k), Good Machine Learning Practice: Development and validation standards, Algorithm Change Protocol: Post-market modification procedures, Transparency and Real-World Performance: Ongoing monitoring requirements. The FDA published its AI/ML Action Plan and continues to develop regulatory frameworks for these rapidly evolving technologies.

Question 7

How often is FDA regulatory news updated and how can I stay informed?

Accepted Answer

FDA regulatory changes occur frequently through guidance documents, warning letters, 510(k) clearances, PMA approvals, and enforcement actions. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Citeline, and Pacific Bridge Medical. We recommend checking this page regularly and subscribing to FDA email updates for critical safety alerts and guidance documents.

Question 8

What commercial sources does this platform use for FDA news?

Accepted Answer

We aggregate FDA regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic FDA announcements, helping you understand the practical implications of regulatory changes.

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