Ângela Silva

May 22, 2024 | jdsupra.com | Michele L. Buenafe |Dennis Gucciardo |Angela Silva |Ângela Silva

While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. The FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device “remanufacturing” and “servicing” activities.

May 22, 2024 | morganlewis.com | Michele L. Buenafe |Dennis Gucciardo |Angela Silva |Ângela Silva

While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. The FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device “remanufacturing” and “servicing” activities.

Sep 18, 2023 | jdsupra.com | Kathleen M. Sanzo |Angela Silva |Ângela Silva

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.

Sep 15, 2023 | morganlewis.com | Kathleen M. Sanzo |Angela Silva |Ângela Silva

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.

May 10, 2023 | lexology.com | Scott Memmott |Howard Young |Jacob Harper |Michele L. Buenafe |Gregory Etzel |Dennis Gucciardo | +12 more

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic.