FDA Announces Key Updates and Approvals – September 8, 2023


Advancements in Device Safety Communication:

   The FDA's Center for Devices and Radiological Health (CDRH) has released a comprehensive report to Congress on Postmarket Device Safety-Related Communications. This initiative aims to equip healthcare providers, patients, and consumers with current information on the benefits and potential risks of medical devices in the market. CDRH's commitment to safety and transparency underscores its dedication to public health.


New Guidance on Biological Evaluation of Medical Devices:

   The FDA has issued final guidance on the use of International Standard ISO 10993-1, focusing on the biological evaluation of medical devices. This guidance includes Attachment G, which outlines recommendations for biocompatibility information in premarket submissions for devices in contact with intact skin. The FDA will host a webinar on October 12, 2023, to provide further insights on this guidance.


Breakthrough Device to Reduce Esophageal Injury Risk:

   The FDA has granted marketing authorization to the S4 Medical Corp.'s Esolution Esophageal Retractor. This catheter-based device is designed to mitigate the risk of esophageal injuries during ablation procedures for treating atrial fibrillation (Afib). Although not a treatment for Afib itself, this device plays a crucial role in minimizing potential complications during ablation procedures.


Grants for Pediatric Device Development:

   The FDA's Pediatric Device Consortia (PDC) Grants Program has awarded a total of $6.75 million to five non-profit consortia. These grants will support research, production, and distribution of pediatric medical devices over the next five years. This initiative aims to address the unique challenges in pediatric medical device development and enhance access to safe and effective devices for young patients.


Strengthening the 510(k) Program:

   The FDA has released three draft guidances to bolster and modernize the 510(k) Program. These efforts are crucial as medical devices become increasingly complex and innovative. Starting October 1, 2023, all 510(k) submissions must be made electronically through eSTAR, a move aimed at enhancing efficiency and compliance.


Workshop on PET Product Quality and Regulatory Framework:

   The FDA has announced a public workshop focused on Positron Emission Tomography (PET) drug manufacturing. This event will serve as a platform for sharing insights and information on the regulatory and compliance framework for PET drug production. The workshop will be held both on-site and virtually on November 13 and 14, 2023.


Outbreak Advisory for Listeria Monocytogenes:

   The FDA issued an update on September 1 regarding an outbreak of Listeria monocytogenes linked to Soft Serve On The Go cups. The Ice Cream House initiated a recall of all affected dairy and non-dairy frozen dessert products manufactured at their facility in Brooklyn, N.Y.


Ultraviolet Germicidal Light System Authorization:

   On September 1, the FDA granted marketing authorization to the Xenex Disinfection Services, Inc., LightStrike+ system. This system utilizes ultraviolet germicidal light to reduce microbial presence on non-porous, non-critical medical device surfaces in clinical settings. It is intended for use in unoccupied rooms after manual cleaning and disinfection.


For more detailed information, please refer to the official FDA statement here:


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