Devices
FDA has approved a Medtronic PMA for the Onyx Frontier drug-eluting stent (DES), indicated for treating patients with coronary artery disease, which is caused by plaque buildup on the inside of the coronary arteries. The device is designed to improve deliverability and will “continue to help interventional cardiologists treat
Devices
Pharmatech Associates managing director Stephanie Gaulding says proposed revisions to FDA’s Quality System Regulation for medical devices “is a significant step toward global harmonization and reduces the amount of U.S.-specific regulations for medical device manufacturers, especially relating to structure and requirements for a medical device quality management
Devices
The Government Accountability Office (GAO) says FDA should develop a policy for using enforcement discretion regarding unauthorized diagnostic tests in future public health emergencies. “This policy should include the conditions under which FDA would begin and end the use of such discretion,” a GAO report says. GAO says it was
Drugs
The U.S. now has a sufficient supply of molybdenum-99 (Mo-99) produced without highly enriched uranium, thanks to efforts by FDA and other government and private organizations. In a CDER From Our Perspective online post, Division of Imaging and Radiation Medicine medical officer Joseph Rajendran says the Center
Devices
Medical device manufacturers should pay close attention to cybersecurity regulatory and legislative developments, expand their internal expertise, and otherwise invest in establishing robust cybersecurity risk assessment, design control, and risk management practices and procedures relating to their devices. That’s the advice of Ropes & Gray attorneys in an online
Devices
FDA has posted a redacted surgical mask 510(k) review memo to assist third-party review organizations. An agency notice says FDA cannot share proprietary information but is creating a library of redacted memos for selected medical devices with a high volume of third-party reviews.
Devices
In a Regulatory Affairs Professional Society interview, outgoing FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional Congressional authorities for its digital health products pathway and other digital programs. In the online interview, he said the authorities FDA needs include being able to use real-
Devices
FDA is cautioning against the use of the Skippack Medical Lab (SML) SARS-CoV-2 Antigen rapid test. An agency notice says the test is not authorized, cleared, or approved by FDA for distribution or use in the United States because SML Distribution has not provided FDA with adequate data
Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, has released for comment a proposed guidance entitled “Principles and Practices for the Cybersecurity of Legacy Medical Devices.” The document is intended to supplement the group’s 2020 guidance on Principles and Practices for Medical Device Cybersecurity
Devices
FDA has posted a draft guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.” The document describes FDA policy on the agency’s participation in the Voluntary Improvement Program (VIP), which is run by the Medical Device Innovation Consortium and uses third-party appraisals
Devices
A new Pew Charitable Trusts survey finds that most participants expressed support for reform that would increase FDA’s oversight of lab-developed tests (LDTs). The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 is a “solid foundation to achieve this goal,” Pew said, adding that Congress should
Devices
Lasik injury advocate and Vision Advocacy president Paula Cofer has stepped up pressure on FDA commissioner Robert Califf, sending him a second “illegal advertisement” for the EVO Visian implantable collamer lens (ICL) and asking that the agency take action against the promotions that are “masquerading as a news article.” The
Devices
FDA is warning about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following Fresenius Medical Care hemodialysis machines (models 2008T, 2008K2, and 2008K). The 2008K2 and 2008K models are no longer manufactured but may still be in
Devices
FDA has published a guidance, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus, with agency recommendations for studies on the medical devices. The document says manufacturers frequently request FDA feedback about feasibility and early feasibility
Devices
FDA has cleared a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection algorithm. The device is designed to aid in the analysis of radiographs instantly from a dentist’s examination chair, according to the company. The clearance is based on trial data
Devices
Attorney Bradley Thompson (Epstein Becker Green) says it is possible to use FDA data on medical device inspection observations and Warning Letters to attempt to determine which observations might lead to Warning Letters. In a detailed online post that goes through the methodology he used as a regulatory data scientist,
Devices
FDA is permitting marketing of Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test, the first in vitro diagnostic test for early detection of amyloid plaque associated with Alzheimer’s disease. An agency announcement says the test is intended to be used in adult patients, age 55
Devices
FDA has released a revised final guidance entitled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The document outlines the agency’s policy to help address current manufacturing limitations or supply chain issues due to disruptions
Devices
FDA is proposing that a Section 518(b) order be issued to require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after 11/2015. In 6/2021, FDA says, Philips recalled certain ventilators, bi-level positive airway pressure,
Drugs
Writing in a New England Journal of Medicine Perspective piece, CDER executives John Concato and Jacqueline Corrigan-Curay say that more than five years after the passage of the 21st Century Cures Act, the terms real-world data (RWD) and real-world evidence (RWE) continue to be used inconsistently and
Devices
FDA has granted Limaca Medical a breakthrough device designation for its Precision-GI endoscopic ultrasound biopsy product. The device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract using the ultrasound visualization endoscope, according to the company. “Precision-GI is deployed and operated through an instrument
Devices
FDA has published three guidances relating to implementing a standard adopted by the International Council for Harmonization (ICH) for electronic transmission of individual case safety reports (ICSRs). The first guidance, E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide—Data Elements and Message Specification, focuses on technical