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King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

King & Spalding on

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Hogan Lovells

FDA issues draft guidance on remote regulatory assessments

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DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

Mintz - Health Care Viewpoints

Evolution & Revolution: Device Policy Priorities at FDA in 2019

Mintz - Health Care Viewpoints on

This post is the first in a series of three in which we recap the Food and Drug Administration’s somewhat difficult year, having spent the majority of it without a permanent Commissioner and facing a slew of political and...more

Hogan Lovells

New draft guidance on MR compatibility for medical devices

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The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

Hogan Lovells

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

Hogan Lovells

FDA Releases Draft Guidance regarding the Low Calorie Sweetener – Allulose

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Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information....more

Hogan Lovells

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

Hogan Lovells on

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more

Hogan Lovells

NRC Issues Draft Guidance on Non-LWR License Application Contents

Hogan Lovells on

This month, the NRC published an early draft regulatory guide on the content of license applications for non-LWRs.  The document is designed to help license applicants apply the NRC’s movement towards a...more

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