FDA Roundup: October 29, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA responded to objections on the agency’s final rule that removed the authorized food contact uses of most phthalates because industry abandoned these uses. The FDA evaluated the objections and concluded that they did not provide a basis for modifying the final rule. However, the FDA is working on an updated safety assessment of the remaining authorized uses, including considering information we have received through our request for information, and phthalates are included on the list of select chemicals under FDA review.
• On Monday, the FDA announced a hybrid meeting, In Vitro Diagnostics (IVD) Roundtable, that will be held on Nov. 12, 2024, at 10 a.m. ET. The meeting will provide a forum to facilitate communication between the FDA and IVD industry. Participants can attend in-person or virtually. Space is limited for in-person attendance. There is no fee to attend, and registration is required. To attend in person, register by Oct. 30, 2024. To attend virtually, register by Nov. 12, 2024.
• On Monday, the FDA shared information about medical device cybersecurity. Like other electronics, medical devices can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. Informed by patient voices and collaborations with industry, government agencies, and health care delivery organizations, the FDA will continue to drive and refine medical device cybersecurity policy. Before Cybersecurity Awareness Month ends, check out these recent publications that may be generally informative to help keep medical devices operating safely.
• On Friday, the FDA issued a safety communication to alert consumers, health care providers, and health care facilities not to use BioZorb Markers and BioZorb LP Markers by Hologic Inc. On Oct. 25, 2024, Hologic announced a voluntary recall for removal of all lots of unused BioZorb Markers. The recall is due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue. 
• On Friday, the FDA granted marketing authorization of Distalmotion, SA’s Dexter L6 System, an electromechanical surgical system intended to repair inguinal hernias through minimally invasive procedures using high-precision surgical endoscopic instruments. The Dexter L6 System includes a console surgeons use to control movements of the different parts of the system, separate carts that can be positioned next to the operating room table, and arms that get attached to the carts and that can hold and manipulate different endoscopic instruments based on motions captured on the surgeon-controlled console. Although the Dexter L6 Surgical System operates using similar principles as other robotically assisted surgery device systems, it allows for the surgeon and the user interface to be in the sterile field, unlike other authorized devices. The Dexter L6 System is intended for use by trained laparoscopic surgeons on patients 22 years of age or older. This authorization reinforces the FDA’s commitment to providing physicians and patients with minimally invasive surgery options to treat relatively common conditions, such as inguinal hernias.
• On Friday, three individuals in London were sentenced for their role in the international importation and distribution of unapproved drugs. The operation seized over £1M ($1.3M) and 1 million illicit pills. This result is the culmination of numerous law enforcement agencies, including the FDA Office of Criminal Investigations (FDA-OCI), working together from across the world for more than three years. The investigation began in October 2020 when U.S. Customs and Border Protection seized numerous shipments sent from the U.K. found to contain illicit drugs. Information sharing between FDA-OCI and the City of London Police led to the successful execution of warrants in the U.S., where illicit unapproved drugs were found.

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