Regulatory Oversight, Medical Devices, FDA Approval

The Importance of a Clinical Trial Strategy

Gardner Law on 6/17/2025

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on 5/27/2025

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

FDA reviews go faster — but with less proof drugs are safer or more effective

Patrick Malone & Associates P.C. | DC Injury... on 1/22/2020

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

Akerman LLP - Health Law Rx on 8/26/2019

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Pro Te: Solutio – Vol. 11, No. 2

Butler Snow LLP on 9/21/2018

In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

Hogan Lovells on 6/19/2018

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject...more

Obtaining FDA clearance or approval of digital health products

Hogan Lovells on 3/15/2018

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance...more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Foley & Lardner LLP on 9/24/2015

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

Regulatory Oversight › Medical Devices › FDA Approval

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