Intellectual Property Protection, FDA Approval, Medical Devices

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on 7/16/2025

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

FDA Approvals of AI Medical Devices Rise Rapidly

Goodwin on 11/1/2024

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing back to 1995....more

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

Knobbe Martens on 8/18/2023

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on 8/7/2023

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Are you Submission Ready? FDA Medical Device Submission Tips & Tricks

Gardner Law on 8/16/2022

Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper Locke on 5/19/2017

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Foley & Lardner LLP on 10/29/2015

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

Intellectual Property Protection › FDA Approval › Medical Devices