Regulatory Oversight, Food and Drug Administration (FDA), Premarket Approval Applications

Are FDA Review Timelines Slipping? What Companies Need to Know

Gardner Law on 5/30/2025

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on 10/25/2023

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

Hogan Lovells on 2/11/2019

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

Hogan Lovells on 12/28/2018

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

Mintz - Health Care Viewpoints on 12/21/2018

The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What...

Hogan Lovells on 10/22/2018

On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...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

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