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 ...
MD&M East

Abiomed’s Impella 2.5 Wins PMA Approval

Impella 2.5, the main product for Danvers, MA-based Abiomed Inc., has received FDA premarket approval (PMA) for use in elective and urgent high-risk percutaneous coronary intervention (PCI) procedures ...
RAPS

PMA Denials: Why so Few?

In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified ...
Nasdaq

United Health Products Provides Update on FDA PMA Application Process

MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company's FDA Premarket Approval (PMA) application process. Following 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 ...
MD&M East

Supreme Court Upholds Preemption Protection for PMA Devices

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 ...
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, ...
Seeking Alpha

United Health Products Reiterates Guidance on FDA PMA Application Process

MESQUITE, NV, June 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – United Health Products, Inc. (UEEC) today provided an update on the company’s FDA Premarket Approval application process. As ...

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 ...