Manufacturers, Medical Devices, CDRH

New FDA Guidance on AI and Medical Products

Troutman Pepper on 4/12/2024

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

FDA Issues Numerous Warning Letters

Gardner Law on 3/12/2024

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on 10/3/2023

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Manufacturers › Medical Devices › CDRH

New FDA Guidance on AI and Medical Products

FDA Issues Numerous Warning Letters

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

AI in Medical Devices and Healthcare: Opportunities, Challenges, and What Lies Ahead

Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs

FDA Names First Acting Director Of Medical Device Cybersecurity

FDA Announces Action Plan for Oversight of AI/ML in Medical Devices

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Manufacturers › Medical Devices › CDRH

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