Deeona Gaskin

Feb 5, 2024 | lexology.com | Deeona Gaskin |Raj Pai |Daniel Roberts |Stephanie Slater

The U.S. Food and Drug Administration (FDA) issued long-awaited revisions to the current good manufacturing practice (CGMP) requirements for finished medical devices on January 31, 2024. These revisions are now known as the Quality Management System Regulation (QMSR). Importantly, the rule amends 21 C.F.R. Part 820 by aligning more closely to the International Organization for Standardization (ISO)13485:2016 requirements, which are used by many regulatory authorities outside of the United States.

Nov 8, 2023 | datamatters.sidley.com | Meenakshi Datta |Elizabeth Hardcastle |Deeona Gaskin |Torrey Cope

The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare.

Nov 7, 2023 | lexology.com | Meenakshi Datta |Elizabeth Hardcastle |Deeona Gaskin |Torrey Cope |Sama Kahook

The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare.

Oct 13, 2023 | law360.co.uk | Becky Wood |Deeona Gaskin |Sean Griffin

ADVERTISEMENT Don't want ads? Subscribe or login now. By Becky Wood, Deeona Gaskin and Sean Griffin (October 13, 2023, 2:09 PM EDT) -- The U.S. Food and Drug Administration recently announced a new rulemaking and a voluntary pilot program in its ongoing attempt to regulate lab-developed tests.[1]...

Jun 8, 2023 | lexology.com | Meenakshi Datta |Deeona Gaskin

Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans. The more complex digital health products currently being developed are combination hardware/software products that include an AI component.