Janice Hogan on FDA Approval

Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more

3/30/2020 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Laboratory Developed Tests , Legislative Agendas , Proposed Legislation , Public Health Service Act , Regulatory Oversight

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

9/6/2019 / FDA Approval , FDA De Novo Clearance , Final Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

1/25/2019 / 510(k) RTA , FDA Approval , Federal Budget , Federal Funding , Food and Drug Administration (FDA) , Government Shutdown , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Standard of Review , Trump Administration , US-Mexico Border Wall

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

12/13/2018 / 510(k) RTA , De Novo Standard of Review , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Standard of Review

FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the...more

11/29/2018 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Innovative Technology , Life Sciences , Medical Devices

FDA proposes streamlining combination product regulations

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

5/31/2018 / 21st Century Cures Act , Administrative Reconsideration , Appeals , Biotechnology , FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Pharmaceutical Industry , Proposed Rules , Regulatory Oversight , Regulatory Standards

FDA’s Software Pre-Cert Program: More Details Revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

8/10/2017 / 21st Century Cures Initiative , Digital Health , FDA Approval , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Medical Software , Regulatory Standards

Janice Hogan

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