Devices
CDRH’s user fee commitments are being negatively impacted by the Center’s top-priority Covid-19 work, director Jeff Shuren told a 12/3 Alliance for a Stronger FDA Webinar. Since the beginning of the Covid-19 emergency, the Center has accepted over 5,000 feedback requests related to
Devices
FDA has updated its 2019 safety communication on Endologix’s AFX endovascular graft systems used in treating abdominal aortic aneurysms (AAA) and the risks associated with Type III endoleaks with the devices. It is reminding patients and health care providers of the importance of at least yearly, lifelong follow-up
Devices
FDA has cleared an Ensemble Orthopedics 510(k) for its Ensemble CMC Implant for treating patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint. The device features a proprietary saddle shape that “replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant that allows
Devices
FDA says it is prioritizing the review of emergency use authorization (EUA) requests for Covid-19 tests based on factors such as the public health need for the product and product availability. An update to the Frequently Asked Questions related to Covid-19 test development and review says the agency
Devices
FDA has cleared a Viveve Medical 510(k) to expand its manufacturing capacity for its consumable treatment tips used with the company’s Cryogen-cooled Monopolar Radiofrequency (CMRF) technology. CMRF is used with the Viveve System, which is indicated for use in general surgical procedures for electrocoagulation and hemostasis. Viveve
Devices
FDA says it has updated the SARS-CoV-2 reference panel comparative data on the agency Web site to reflect the latest information. An FDA notice says the reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical
Devices
FDA has published a Web page with answers to frequently asked questions relating to the development and use of transport media during the Covid-19 public health emergency. “These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify existing policies,” the
Devices
Fujirebio Diagnostics has submitted a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in assessing Alzheimer’s disease. The test uses Fujirebio’s automated Lumipulse G1200 instrument system to analyze results. According to Fujirebio, the device combines the concentrations
Devices
FDA has posted the transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act (MDUFA) program. During the meeting, FDA commissioner Stephen Hahn acknowledged the resource strain from the current Covid-19 emergency on the Center’s ability to continue to meet user fee
Devices
The Association for the Advancement of Medical Instrumentation (AAMI) has published a consensus report with guidelines for implementing remote control for many critical medical devices during the Covid-19 pandemic. An AAMI announcement (includes a link to the guidelines) says FDA has already issued emergency use authorizations for many remote
Devices
The Medical Device Innovation Consortium (MDIC) says it has formed a Working Group, sought by FDA, focusing on 5G-enabled health technologies. MDIC says working group stakeholders are subject matter experts and senior-level executives from medical device manufacturers, 5G network operators, 5G chipset and network equipment manufacturers, wireless service
Devices
FDA says its review of the Industry Lab Diagnostic Partners Web site determined that the firm is offering a Covid-19 at-home sample collection kit that is considered a medical device that is being marketed without marketing approval, clearance, or authorization from the agency. An 11/20 Warning Letter
Devices
Baxter Healthcare is recalling its Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning may lead to residue build-up or corrosion on the device. “If the device is running only on battery
Devices
FDA has recognized A2LA, a non-governmental third-party accreditation body, as a participant in the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. With FDA recognition, A2LA will be able to assess testing laboratories seeking ASCA accreditation to perform a premarket assessment for medical device companies.
Devices
FDA has approved a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor that occurs most often in the long bones of the leg, such as the femur and tibia, of young children and adolescents. The condition causes a dull, aching pain
Devices
FDA has updated a guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the Covid-19 Public Health Emergency, to further assist manufacturers in providing the agency with timely and informative notifications about changes in
Devices
Two Massachusetts Eye and Ear Hospital doctors say FDA should use the 510(k) pathway to clear over-the-counter hearing aids. Writing in a Perspective column in the New England Journal of Medicine, the doctors say the agency has missed its legislatively-mandated deadline to release rules governing over-
Devices
FDA has cleared a CorticoMetrics 510(k) for Thinq, its artificial intelligence-based software for use by radiologists and neurologists to provide quantitative information to augment patient assessment for a number of neurological disorders and conditions. The device reports volumetric measurements and visualizations of 30 critical brain structures, and compares
Devices
FDA has issued an immediately-in-effect guidance, Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus 2019 (Covid-19) Public Health Emergency, saying that the agency does not intend to object to using dry heat systems
FDA Policy/General
Three Covington & Burling attorneys say a stronger regulatory focus can be expected at FDA in the administration of president-elect Joe Biden. In an online post, the attorneys outline their expectations by Center and program. CBER and CDER * additional effort to promote generic and biosimilar competition; * supply chain and
Devices
During an 11/12 online listening session for the CDRH Digital Health Center of Excellence (DHCoE), a panel of industry experts discussed whether FDA has developed the correct goals for the DHCoE and how best to collaborate on the Center’s work. DHCoE director Bakul Patel said FDA considers digital
Devices
FDA has cleared a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its NeuroStar Advanced Therapy System. “The new protocol arms physicians with the ability to now offer a third FDA-cleared treatment protocol with NeuroStar Advanced Therapy, a non-drug,