SCOTUSblog

Argument recap: Riegel v. Medtronic

Allison Zieve, arguing on behalf of the petitioner, began by discussing the PMA process and stressing what PMA is and what it isn’t. Notably, Ms. Zieve argued, the FDA grants the PMA if the ...
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 ...
Medscape

FDA Recommends Changes to 510(k) Process

August 6, 2010 (Silver Spring, Maryland) — As the Institute of Medicine continues its review of the FDA's 510(k) clearance process for devices that do not require full premarket approval (PMA) review, ...

Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
JD Supra

Indiana State and Federal Courts Rule That Manufacturing Defect Claims May Survive Preemption in PMA Context

Indiana courts have recently addressed preemption issues in matters involving devices approved by the Food and Drug Administration (FDA) through the premarket approval (PMA) process. First, the ...