SILVER
SPRING, Md., Aug. 6, 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 issued a Safety Alert advising restaurants
and retailers not to serve or sell, and consumers not to eat
certain oysters from Lewis Bay,
Massachusetts, due to potential
contamination with Campylobacter jejuni.
- On Monday, the FDA's Center for Devices and Radiological Health
(CDRH) released a Discussion Paper: Health Equity For Medical
Devices to obtain feedback about ways to help ensure that all
patients have timely access to safe, effective, and high-quality
medical devices and safe radiation-emitting products. This paper
requests feedback on possible considerations that may help inform
the design of a clinical study that adequately reflects the
intended use population for a particular medical device. Consistent
with CDRH's 2022 to 2025 Strategic Priority to advance health
equity, this paper is intended to spur discussions about reducing
barriers to achieving health equity and strategies that may help
improve outcomes across diverse populations. Please submit comments
under docket number FDA-2024-N-3616 at www.regulations.gov by
October 4, 2024.
- On Monday, the FDA's Digital Health Center of Excellence
(DHCoE) published its summer edition newsletter that shares the
latest digital health advancements to protect and promote public
health. As AI continues to advance with more sophisticated
algorithms and more data available than ever before, it's important
to consider ways to align on methodologies, best practices, and
quality assurance standards to help all people living in the U.S.
truly benefit from AI's tremendous capability in health care
settings. In this edition, DHCoE explores these concepts and
potential approaches for addressing these questions.
- The FDA's Office of Regulatory Affairs (ORA) has partnered with
the National Association of State Departments of Agriculture
(NASDA) and the North Carolina State
University (NC State) to create
a new course to introduce degree and non-degree seeking students to
the possibilities of a career in public health. This dynamic new
course, Introduction to Public Health Food Inspections, is
the first of its kind anywhere in the country and offers students a
comprehensive understanding of the federal regulatory food
inspections and enforcement system. To learn more about this
dynamic new course, please visit www.nasda.org/inspectioncourse.
Completion of the course offers students college credit to build
their resumes as well as a potential pathway for equivalency
testing for specific topics. Students with these credentials and
training will be sought after by the Agency and should strongly
consider applying for vacant positions advertised on USA Jobs, and for positions with our state and
local public health partners. In the future, the FDA and NASDA hope
this course can be replicated at other higher education
institutions across the country.
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