SILVER
SPRING, Md., May 10, 2024
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is
providing an at-a-glance summary of news from around the
agency:
- On Thursday, the FDA provided information on how to safely
charge hearing aids, glucose monitors, insulin pumps, and other
medical devices to avoid overheating. Medical devices with
rechargeable batteries meet important medical needs, but if they
are not charged properly, they can overheat, which may result in
fires, or cause minor injuries or serious burns.
- On Thursday, the FDA announced a webinar that will be held on
June 27, 2024, for those interested
in learning more about the final guidance Remanufacturing of
Medical Devices. This final guidance is a part of the FDA's
ongoing efforts to help distinguish between remanufacturing and
servicing. It clarifies whether activities performed on devices are
likely "remanufacturing," which differs from servicing activities
such as maintenance and repair. This clarification is intended to
help ensure consistency and a better understanding of the
regulatory requirements applicable to remanufacturers.
Additionally, the guidance recommends information to be included in
the labeling of reusable medical devices to help ensure their
continued quality and safety during servicing.
- On Thursday, the FDA announced that Sol-Millennium Medical,
Inc. initiated a recall to stop using affected products, which
includes unauthorized plastic syringes made in China such as "combined" syringes with needle
and syringe components packaged together, low dead space ("LDS")
syringes, luer slip tip syringes, eccentric tip syringes, and
syringe accessories. The FDA recommendations have not changed. The
FDA will continue efforts to evaluate problems with syringes made
in China and keep the public
informed as new or additional information becomes available.
- On Thursday, the FDA advised consumers in Tips to Stay Safe in
the Sun: From Sunscreen to Sunglasses that sun safety is always in
season. Although all sunscreens help protect people from sunburn,
only broad-spectrum sunscreens with a sun protection factor (SPF)
of at least 15, when used as directed with other sun protection
measures. help protect us from skin cancer and early skin aging
caused by the sun. The FDA continues to evaluate sunscreen products
to ensure that their active ingredients are safe and effective.
- On Wednesday, the FDA's Center for Tobacco Products (CTP)
announced a webinar to be held on June 11,
2024, from 3:00 to 4:15 p.m.
ET to commemorate the 10th anniversary of the award-winning
"The Real Cost" youth tobacco prevention campaign. CTP will provide
information about the impact of the campaign on youth tobacco use
and the importance of public education to the center's
comprehensive tobacco regulation efforts. The webinar is free of
charge, but prior registration is required.
- On Wednesday, the FDA alerted health care providers and
facilities about the agency's continued safety and quality concerns
with Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue
Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet
Cardiohelp system and HLS Sets. The FDA recommends that health care
providers and facilities transition away from these devices and
seek alternatives, if possible. These recommendations are based on
the FDA's continued concerns that Getinge/Maquet has not
sufficiently addressed the problems and risks with these recalled
devices.
- On Tuesday, the FDA announced registration has opened for the
June 27 public workshop to be hosted
in partnership with the Reagan-Udall Foundation for the FDA,
Understanding Current Use of Ketamine for Emerging Areas of
Therapeutic Interest. This workshop will bring together clinicians,
academic researchers, patients and patient advocates, professional
organizations, and federal partners to explore such topics as: the
scope of ketamine use, including approved products and compounded
products, for emerging areas of therapeutic interest; potential
safety concerns; and online promotion of and access to
ketamine.
- On Tuesday, the FDA announced a risk-based decision based on
its review of safety and quality data and information and does not
expect the developer of PrecisePRP Equine (equine leucoreduced
allogeneic pooled freeze-dried platelet-rich plasma) to submit an
application for approval prior to marketing. PrecisePRP Equine
provides a species-specific source of concentrated platelets in
plasma for injection directly into a horse's joint (intra-articular
injection). PrecisePRP Equine is the second animal cell, tissue,
and cell- and tissue-based product (ACTP) intended for
intra-articular use to undergo FDA review and receive this
determination, and it is the first such product for use in
horses.
- On Monday, the FDA issued a Federal Register notice announcing
a meeting of the Tobacco Products Scientific Advisory Committee
(TPSAC) scheduled for June 26, 2024,
at the FDA White Oak campus. The committee will discuss the renewal
of a risk modification order, submitted by Swedish Match
USA, Inc. for 8 loose snus and
portioned snus products. Additional discussion about broader
Modified Risk Tobacco Products program developments related to the
conceptualization and measurement of consumer understanding will
also occur.
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