Randy Prebula on Draft Guidance

FDA and OHRP publish draft guidance on facilitating understanding in informed consent

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of...more

3/12/2024 / Department of Health and Human Services (HHS) , Draft Guidance , Food and Drug Administration (FDA) , Informed Consent , Proposed Rules

FDA finalizes advice on cybersecurity info to include in device submissions

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which advises medical device manufacturers on...more

10/4/2023 / Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Popular

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more

5/5/2023 / Clinical Trials , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Telehealth

FDA Breakthrough Devices Program guidance targets health inequality

The U.S. Food and Drug Administration (FDA) recently issued the draft guidance “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care,” which proposes updates to the...more

11/15/2022 / Comment Period , Disparate Impact , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

FDA updates “cybersecurity in medical devices” guidance, seeks industry input - Draft guidance addresses quality system...

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which aims to help industry take a more...more

4/15/2022 / Cybersecurity , Data Breach , Data Privacy , Data Protection , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Popular

FDA explains when medical device makers must notify of an interruption in manufacturing

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more

1/14/2022 / CARES Act , Comment Period , Coronavirus/COVID-19 , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Public Health Emergency , Public Health Service Act

COVID-19 Report for Life Sciences and Health Care Companies - January 2022

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more

1/12/2022 / Coronavirus/COVID-19 , Draft Guidance , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Infectious Diseases , Life Sciences , Medical Devices , Pharmaceutical Industry , Vaccinations

FDA transition plan for COVID-19 medical devices requests new submissions to agency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more

1/11/2022 / Coronavirus/COVID-19 , Draft Guidance , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Public Comment , Public Health Emergency

FDA issues draft guidance on providing regulatory submissions in electronic format

On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published adraft guidance document entitled "Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section...more

9/28/2019 / Draft Guidance , Electronic Reporting , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices

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

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

2/11/2019 / 21st Century Cures Act , Combination Products , Comment Period , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Premarket Approval Applications , Regulatory Oversight , Regulatory Requirements

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more

10/10/2018 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Randy Prebula

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