The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more
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 effectiveness of robotically-assisted surgical (RAS) devices for use in...more
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket review of Laboratory Developed Tests...more
Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more
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
The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than...more
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
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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 Novo Classification Requests."
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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
On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in one of the first FDA enforcement...more
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
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
12/28/2018
/ Center for Drug Evaluation and Research (CDER) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Trump Administration
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
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
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
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
In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more