MD&M East

Supreme Court to Consider Preemption for PMA Devices

The medical device amendments state the principal that federal rules preempt requirements established under state law (Sec. 360k(a)). This express preemption clause provides, in part, that no state ...
MarketWatch

Intro to Medical Device Submission Virtual Course: Navigating FDA Pathways - 510(k), IDE, De Novo, and PMA Requirements for Medical Device Approval in the U.S. (Oct 9, 2025 ...

The "Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions (Oct 9, 2025)" training has been added to ResearchAndMarkets.com's offering. The regulation and control of new or substantially ...
MD&M East

Supreme Court Upholds Preemption Protection for PMA Devices 4448

On February 20, the U.S. Supreme Court handed Medtronic Inc. (Minneapolis) a resounding victory in a much-watched and long-fought product liability dispute. In issuing their landmark decision, the ...
TCTMD

The More Tweaks Made to PMA-Approved Devices, the More Likely a Recall

Medical devices cleared under the US Food and Drug Administration’s premarket approval (PMA) pathway are more likely to undergo a recall if their manufacturers have filed additional documentation with ...
JD Supra

FDA Issues Final Guidance on Filing PMAs and 510(k)s

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...