FDA Roundup: September 8, 2023

SILVER SPRING, Md., Sept. 8, 2023 /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’s Center for Devices and Radiological Health (CDRH) published a Postmarket Device Safety-Related Communications Report to Congress. CDRH strives to provide current information concerning the benefits and risks of marketed medical devices to health care providers, patients and consumers so they can make informed treatment and diagnostic decisions. This report provides information on sources of data and types of communications used to inform the public of problems or potential problems with devices that are on the market.

CDRH is charged with protecting and promoting the public health and ensuring that the over 238,000 different types of medical devices CDRH regulates are safe and effective for patients in the United States.
On Thursday, the FDA issued the final guidance: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” This guidance adds, within a new attachment (Attachment G), recommendations which reflect the agency’s current thinking about the type of biocompatibility information that should be provided in a medical device premarket submission for certain devices in contact with intact skin. CDRH will host a webinar on Oct. 12, 2023 for industry and others interested in learning more about the guidance.
On Wednesday, the FDA granted marketing authorization to the S4 Medical Corp., Esolution Esophageal Retractor, a catheter-based device intended to reduce the risk of injuries to the esophagus that may occur during an ablation procedure to treat atrial fibrillation (Afib). Afib is the most common type of treated heart arrhythmia. According to the Centers for Disease Control and Prevention, it is estimated that 12.1 million people in the United States will have AFib in 2030. While the device is not intended to treat Afib, it can help reduce the risk of an ablation-related esophageal injury, which can be a serious complication during an ablation procedure. The device is inserted in a patient’s mouth, into the esophagus, and uses mechanical force and vacuum suction to move the esophagus away from the source of ablation energy.
On Wednesday, the FDA’s Pediatric Device Consortia (PDC) Grants Program awarded grants to five non-profit consortium totaling $6.75 million. The grants will be allocated to each consortium annually over the next five years, contingent upon availability of federal funds and consortia performance, to fund advancements in research, production and distribution of pediatric medical devices.

“Pediatric medical device development faces unique challenges as children often differ from adults in size, growth, development and body chemistry,” said Sandra Retzky, D.O., J.D., MPH, director of the FDA’s Office of Orphan Products Development. “The FDA funds the Pediatric Device Consortia grants program to advance development of pediatric medical devices. The collective expertise of the consortia plays a vital role in the FDA’s efforts toward enhancing access to safe and effective medical devices for all pediatric patients.”

This year’s awards include commitments to developing clinical trial infrastructure, advancing diversity and health equity as well as real-world evidence projects. This year’s grantees include:

Southwest National Pediatric Device Innovation Consortium
Alliance for Pediatric Device Innovation
UCSF-Stanford Pediatric Device Consortium
The Consortium for Technology & Innovation in Pediatrics: CTIP 3.0
Midwest Pediatric Device Consortium

On Wednesday, the FDA issued three draft guidances intended to support efforts to continue to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices as they become more complex and innovative.

Additionally, as part of the FDA’s efforts to modernize the 510(k) Program and implement MDUFA V, starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the Electronic Submission Template for Medical Device 510(k) Submissions final guidance. eSTAR is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions.
On Wednesday, the FDA announced the public workshop “Positron Emission Tomography Product Quality Regulatory Submissions, Facility Inspections and Benefit-Risk Considerations.” The purpose of this workshop is to provide a forum for the exchange of information and perspectives on the regulatory and compliance framework for Positron Emission Tomography (PET) drug manufacturing. The meeting will be held Nov. 13 and 14 on-site and virtually. Registration is required for both online and on-site attendance.
On Sept. 1, the FDA issued an update for the advisory for the outbreak of Listeria monocytogenes linked to Soft Serve On The Go cups. The Ice Cream House initiated a recall to include all dairy and non-dairy [parve] frozen dessert products manufactured at The Ice Cream House facility in Brooklyn, N.Y. See the Outbreak Advisory for additional information.
On Sept. 1, the FDA authorized marketing of the Xenex Disinfection Services, Inc., LightStrike+ system which emits ultraviolet germicidal light to reduce the number of microbes present on non-porous, non-critical medical device surfaces in the health care environment, after manual cleaning and disinfection. Non-critical medical devices are those that may touch a patient but not penetrate the skin, or devices that do not directly come into contact with the patient but may become contaminated during patient care. The system is intended for use in unoccupied rooms in clinical settings, such as operating rooms, patient examination rooms or in-patient hospital rooms.

Additional Resources:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540

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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, products that give off electronic radiation, and for regulating tobacco products.