FDA Roundup: September 17, 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• Today, the FDA issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.

  Traditional randomized controlled drug trials typically capture a large amount of patient information at baseline and over the course of the trial. Health care professionals may also collect this data in routine clinical practice interactions with patients. Researchers may be able to use that data to satisfy trial data requirements, reducing the need for dedicated trial sites and duplicative data entry. This may improve convenience and accessibility for participants and allow for enrollment of more representative populations, resulting in more generalizable trial results.

• Today, the FDA issued a final guidance, “Conducting Clinical Trials with Decentralized Elements,” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.

  Decentralized elements allow trial-related activities to occur remotely at locations that are convenient for trial participants. Decentralized elements may include telehealth visits, in-home visits with remote trial personnel, or visits with local health care providers. In this guidance, a decentralized clinical trial (DCT) refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility. This guidance is a part of the FDA’s commitment to advance innovation in clinical trial design and conduct.

• Today, the FDA issued a safety communication to alert patients, caregivers, health care providers, and health care facilities about the increased risk of thigh bone fracture after surgery (postoperative periprosthetic femoral fracture) with the use of the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System). Given recent research that found a higher risk of thigh bone fracture with the CPT Hip System compared to hip prostheses of a similar design, the FDA recommends health care providers and facilities consider using an alternative prosthesis where possible, and if not possible, inform the patient of the increased risk. 
• On Monday, the FDA announced the inaugural Digital Health Advisory Committee meeting that will occur Nov. 20-21, 2024. During this meeting, the advisory committee will discuss total product lifecycle considerations for generative AI-enabled medical devices and how the use of generative AI may impact safety and effectiveness of medical devices enabled with this technology. Additionally, the committee will discuss premarket performance evaluation, risk management, and postmarket performance monitoring for generative AI-enabled devices. Registration is not required to attend. Additional details and important deadlines are at Digital Health Advisory Committee Meeting.
• On Friday, the FDA cleared for marketing Apple Inc.’s Sleep Apnea Notification Feature (SANF), an over-the-counter software-only, mobile medical application that analyzes Apple Watch sensor data to identify patterns of breathing disturbances suggestive of moderate to severe sleep apnea and provide a notification to the user. This device is intended for adults 18 years or older who have not previously received a sleep apnea diagnosis. It is not intended to diagnose, treat, or aid in the management of sleep apnea. The absence of a notification is not intended to indicate the absence of sleep apnea.
• On Friday, the FDA issued six warning letters to manufacturers and retailers for the sale or distribution of unauthorized e-cigarette products promoted at an industry trade show. The FDA also announced the issuance of warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog, and Raz.

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