SILVER
SPRING, Md., May 14, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration
is providing an at-a-glance summary of news from around the
agency:
- On Monday, the FDA's Office of Science and Engineering
Laboratories launched an improved online Regulatory Science Tool
(RST) Catalog to enhance search and browse capability as well as
allow for long-term growth in published tools. The RST Catalog is
now organized by research program and device type, cross referenced
by both program and RST category, and an online portal for many
OSEL-developed applications including the Device and Material
Safety Evaluation Library. The RST Catalog will continue to provide
peer-reviewed resources for medical device companies and
innovators.
- On Monday, the FDA announced the virtual Medical Device
Sterilization Town Hall – Sterilization Method Selection for New
and Existing Devices that will be held on Thursday, May 23, 2024, at 1-2:15 p.m. ET. During this town hall, the FDA
will host a panel discussion for what to consider when choosing a
sterilization method or changing methods. Registration is not
required to attend. Please submit any questions to
MedicalDeviceSterilization@fda.hhs.gov at least one week in
advance.
- On Monday, the FDA issued a safety communication to warn
patients, caregivers, and health care providers not to use Cue
Health's COVID-19 Tests due to an increased risk of false results.
The FDA had also issued a Warning Letter to Cue Health after an
inspection revealed that the company made changes to these tests
and that the changes reduced the reliability of the test to detect
SARS-CoV-2 virus.
- On Monday, the FDA added 191 devices to the list of artificial
intelligence and machine learning (AI/ML)-enabled devices legally
marketed in the United States by
510(k) clearance, granted De Novo request, or premarket approval.
With this update, the list includes 882 AI/ML-enabled medical
devices authorized through March 31,
2024. This list is not meant to be an exhaustive or
comprehensive resource of AI/ML-enabled medical devices. Rather, it
is a list of AI/ML-enabled devices across medical disciplines,
based on publicly available information. The FDA maintains this
list to increase transparency about AI/ML-enabled devices in this
rapidly progressing field.
- On Friday, the FDA posted a new video in the "FDA In Your Day"
series. In this video, Principal Deputy Commissioner Dr. Namandjé
Bumpus discusses biosimilars, anti-choking protocols, home as a
health care hub initiative, and high blood pressure education
month.
- On Friday, the FDA announced that it does not intend to enforce
new animal drug approval requirements for products compounded from
GS-441524, when prescribed by a veterinarian for a specific cat
patient for the treatment of Feline Infectious Peritonitis, under
the conditions listed in Guidance for Industry (GFI) #256
Compounding Animal Drugs from Bulk Drug Substances.
- On Friday, the FDA announced it had conditionally approved the
first torsemide animal drug for dogs. UpCard-CA1 (torsemide oral
solution) was conditionally approved for use with concurrent
therapy with pimobendan, spironolactone, and an
angiotensin-converting enzyme (ACE) inhibitor for the management of
pulmonary edema (fluid build-up in lungs) in dogs with congestive
heart failure caused by myxomatous mitral valve disease
(MMVD).
Additional Resources:
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration