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After a long and winding road, FDA finalizes much-debated “intended use” rule

USA - August 5 2021 On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR §…

Suzanne Levy Friedman, Heidi Gertner, Jane Kalinina, Philip Katz, Susan S. Lee, Randy Prebula, Blake E. Wilson

HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority

USA - August 23 2020 On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug…

Janice M. Hogan, Susan D. Tiedy-Stevenson, Erkang Ai, Brooke Bumpers, Randy Prebula

Talking The Cure: Discussing FDA authorities for handling a global pandemic for medical devices

USA - March 12 2020 In this episode, Michael S. Heyl and Jonathan S. Kahan explore questions around FDA’s Emergency Use Authorization authorities, how it has been used…

Michael S. Heyl

Pilot program for 510(k) electronic submissions is requesting participants

USA - March 2 2020 The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic…

Janice M. Hogan, Randy Prebula

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

USA - February 25 2020 The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators…

Kristin Zielinski Duggan