Devices
FDA has published a guidance, Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, to ensure safe and effective use and provide recommendations for the content of premarket submissions. The document says Physiologic Closed-Loop Control (PCLC) technology “can enable automation in a variety of medical device types.
Biologics
FDA has published a draft guidance, Graft-versus-Host Disease: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment, to assist sponsors in developing such products. Specifically, the document addresses the agency’s current thinking about the overall clinical development program and critical design elements for early- and
Devices
FDA has cleared a Boston Scientific 510(k) for its AVVIGO+ Multi-Modality Guidance System, which the company describes as a streamlined platform that enhances the intravascular imaging and physiology experience. It is intended to integrate best-in-class percutaneous coronary intervention (PCI) guidance tools into one system, “so users
Devices
In a study co-published with the Pittsburgh Post-Gazette, the investigative journalism newsroom ProPublica says Philips Respironics kept adverse event reports about their CPAP machines and ventilators from FDA for a decade while aggressively marketing the troubled machines. “Company insiders said the devices posed an ‘unacceptable risk,’” the report
Devices
FDA has cleared a Trax Surgical 510(k) to market its Trax Compression Screw System that offers a wide range of bone screws for osteotomy, fixation, fusion, and fracture procedures. The company says the device comprises headed and non-headed titanium screws that are each cannulated and self-tapping. They
Devices
FDA has published a guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document represents the agency’s current thinking on the topic and says that for applications currently pending with FDA and those submitted after publication of the guidance, the agency intends to work
Devices
FDA has cleared a Profound Medical 510(k) for the company’s Thermal Boost module for use in conjunction with its Tulsa-Pro, which permits surgeons to ablate whole- or partial-gland prostate tissue in patients with low-, intermediate-, or high-risk prostate cancer; with benign prostatic hyperplasia (BPH); as
Devices
FDA has cleared an Exactech 510(k) for its Activit-E polyethylene for the Vantage Total Ankle System. The company says the “advanced material” provides the “best-wear performance we’ve tested combined with higher fracture toughness than other highly crosslinked vitamin E polyethylenes.” It says manufacturing process replaces gamma
Devices
U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) have introduced bicameral legislation to improve the medical device recall process. Their Medical Device Recall Improvement Act would require FDA to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA,
Devices
Three Hogan Lovells attorneys say FDA published 9/8 an updated final guidance on using the international standard ISO 10993-1, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process. Writing in an online post, the attorneys say the guidance further harmonizes the agency’
Devices
Terumo’s MicroVention unit has been granted 510(k) clearance for its SOFIA EX 5F 115 cm intracranial support catheter for transradial access in addition to transfemoral access in neurointervention procedures. The device was designed to allow for “great trackability,” the company says, adding that a large inside lumen provides
Devices
Medline Industries is recalling (Class 1) its Hudson RCI Addipak unit dose vial, 0.9% full normal saline solution (Lot 3B085) due to sterility concerns. The affected lot passed sterility testing, but another lot within the same cleaning cycle (Lot 3B087) failed the testing, exposing the affected lot to potential
Devices
FDA has issued a draft Center for Devices and Radiological Health (CDRH) International Harmonization Strategic Plan. A CDRH statement (contains a link to the draft plan) says the plan “includes specific strategies to directly encourage harmonization, convergence, and reliance among medical device regulatory authorities, as applicable, and builds on the
Devices
Three Ropes & Gray attorneys say FDA likely has more significant reforms in mind than the recent three draft guidances to modernize and update the 510(k) medical device approval pathway. Writing in an online post, the attorneys analyze the three draft guidances, while suggesting that the agency is considering
Devices
FDA says that as of 9/19, its medical device Accreditation Scheme for Conformity Assessment (ASCA) program is converting from a pilot to a permanent program. The notice says the program will continue to be implemented through its final guidance document. ASCA is described as an accreditation scheme that capitalizes
Devices
FDA has granted InBrain Neuroelectronics a breakthrough device designation for its Intelligent Network Modulation System and its use as an adjunctive therapy for treating Parkinson’s disease. “The InBrain system harnesses the power of graphene, a two-dimensional material made of a lattice of carbon atoms only one atom thick,
Devices
FDA is announcing a 9/29 virtual public workshop entitled “Patient-Reported Outcomes and Vision-Related Quality of Life Questionnaires,” which is intended to highlight the importance of patients’ perspectives, patient-reported outcomes (PROs), and questionnaires to measure visual function and vision-related quality of life (VFQs) in vision research
Devices
FDA has cleared a B. Braun Medical 510(k) for its AQUAbase nX Reverse Osmosis System. The single-stage device is intended for use in providing high-quality water for dialysis patients without the use of chemicals. It is designed to provide up to a 75% raw water conversion rate
Devices
CDRH has developed a Digital Health Frequently Asked Questions (FAQ) Web page to help developers bring innovative technologies to market. The Center encourages developers to contact its Digital Health Center of Excellence (DHCoE) throughout the development process with questions about digital health regulatory considerations. If after a developer has reviewed
Devices
FDA has cleared a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine-learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep. The device allows patients to participate in clinically validated, EEG-
Devices
FDA has published a guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, to describe agency policy in participating in the program. The document says the Voluntary Improvement Program (VIP) is a voluntary program facilitated through the Medical Device Innovation Consortium that evaluates the capability
Devices
FDA has published a guidance, Breakthrough Devices Program, describing policies the agency will use to implement sections of several laws that authorize that program. The document supersedes one issued on 12/18/2018. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products