Janice M. Hogan
Hogan Lovells
Articles
FDA warns over use of robotically-assisted surgical devices
USA - August 27 2021 Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and…
Lina R. Kontos, Kristin Zielinski Duggan, Kelliann H. Payne, Randy Prebula
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…
Susan D. Tiedy-Stevenson, Erkang Ai, Brooke Bumpers, Jonathan S. Kahan, Randy Prebula
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…
Final guidance provides additional clarity to the Humanitarian Device Exemption program
USA - September 10 2019 On 6 September 2019 the U.S. Food and Drug Administration (FDA or the Agency) issued its final guidance document entitled "Humanitarian Device…
Susan D. Tiedy-Stevenson, Jennifer Agraz Henderson, Kelliann H. Payne, Randy Prebula
De Novo requests: FDA releases updated RTA checklist
USA - September 9 2019 On 9 September 2019 the U.S. Food and Drug Administration (FDA or the Agency) issued its final guidance document entitled "Acceptance Review for De…
Jennifer Agraz Henderson, Yarmela Pavlovic, Kelliann H. Payne, Randy Prebula, John J. Smith
