Paige Cappelli on Food and Drug Administration (FDA)

FDA Releases Draft Guidances on 510(k) Submissions

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving...more

9/15/2023 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Public Comment

FDA Seeks $7.2 Billion Budget for 2024

The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested budget directed to advancing access to...more

3/21/2023 / Budgets , Food and Drug Administration (FDA) , Medical Devices , Supply Chain

FDA to Collaborate with Veterans group on Medical Device Innovation

On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help...more

10/10/2022 / Food and Drug Administration (FDA) , Innovation , Medical Devices , Popular

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more

5/12/2022 / Comment Period , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform

FDA Issues Draft Guidance for Software Contained in Medical Devices

On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more

11/10/2021 / Digital Health , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Software , Pharmaceutical Industry , Premarket Approval Applications

FDA Taking Steps to Prevent Future Medical Device Shortages

The medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. ...more

7/29/2021 / Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Supplies , Pharmaceutical Industry , Supply Chain

Paige Cappelli

Knobbe Martens

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

FDA Releases Draft Guidances on 510(k) Submissions

FDA Seeks $7.2 Billion Budget for 2024

FDA to Collaborate with Veterans group on Medical Device Innovation

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

FDA Issues Draft Guidance for Software Contained in Medical Devices

FDA Taking Steps to Prevent Future Medical Device Shortages

Paige Cappelli

Knobbe Martens

Popular Topics by This Author

Latest Posts › Food and Drug Administration (FDA)

FDA Releases Draft Guidances on 510(k) Submissions

FDA Seeks $7.2 Billion Budget for 2024

FDA to Collaborate with Veterans group on Medical Device Innovation

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

FDA Issues Draft Guidance for Software Contained in Medical Devices

FDA Taking Steps to Prevent Future Medical Device Shortages

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