Devices
FDA has granted Becton, Dickinson and BioGX an emergency use authorization for a new diagnostic test that will enable hospitals to screen for Covid-19 ) on site and get results in under three hours. The test will be run on the BD Max System, a molecular diagnostic platform already in
Devices
An 11/4-11/7/19 FDA inspection at Okamoto Rubber Products, Klongluang, Pathumthani, Thailand, found Quality System Regulation violations in the firm’s production of lubricated natural rubber condoms. A just-released 2/14 Warning Letter says specific violations were: * failing to adequately ensure that when the results of
Devices
A 10/22-10/25/19 FDA inspection at E-Care Technology, Chubei City, Taiwan, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of the Swaive thermometer. A just-released 3/2 Warning Letter says specific violations were: * failing to establish and maintain design
Devices
FDA has announced a 5/5 public meeting entitled “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027” that will be available by Webcast. The meeting is scheduled to discuss proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027. To
Drugs
AdvaMed says it is proposing minor revisions to improve the clarity and impact of an FDA draft guidance on bridging for drug-device and biologic-device combination products. The association’s comment letter says AdvaMed stands ready to assist the agency in finalizing the guidance and developing additional policies that
Biologics
An FDA Office of Bioresearch Monitoring Operations 6/24-6/28/19 inspection at Steiner Biotechnology, Henderson, NV, found “objectionable conditions” related to the firm’s participation in nonclinical Good Laboratory Practice studies concerning the Skeletal Graft and Ridge Graft. A just-released 2/3 Warning Letter says specific deviations
Devices
FDA says it is proposing to reclassify two types of hepatitis C virus (HCV) diagnostic tests from Class 3 to Class 2. If the reclassification is finalized, devices of that type could go through the 510(k) pathway instead of the PMA pathway, an agency notice says. As Class 2
Devices
Medtronic has recalled (Class 1) its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside a patient. “Fractured pieces of the delivery system could be left inside the patient’s brain bloodstream,
Devices
FDA has issued an emergency use authorization for the NeoMoDx SARS-CoV-2 assay running on the NeuMoDx molecular systems. The company says the assay is a rapid, automated, in vitro real-time diagnostic test for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal, oropharyngeal, and nasal
Devices
CME America has recalled the BodyGuard Infusion Pump Systems because they may under or over infuse medications. The reason for the infusion errors is not known, a recall notice says. Using an affected infusion pump may cause serious adverse health consequences including death, it says. To date, there have been
Drugs
Coalition for a Prosperous America chief economist Jeff Ferry says it’s time for the United States to restore its capability to manufacture medical items here, rather than relying on a global supply chain. Writing in an opinion column, Ferry says that equipment needed to fight the Covid-19 virus
Devices
FDA has released a guidance on “Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The document says that during the coronavirus outbreak, the agency does not intend to object to “limited modifications to the indications or functionality of FDA-
Drugs
With the president’s signing of the $2 trillion stimulus bill 2/27, FDA says it is pleased with an additional $80 million to fund its Covid-19 response efforts. The funding will go to developing medical countermeasures and vaccines, promoting advanced manufacturing for medical products and monitoring the medical
Drugs
FDA has released a guidance on “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” During the Covid-19 pandemic, FDA has been closely monitoring the medical product supply chain to see how it may be impacted by the outbreak.
Devices
FDA has approved a Zoll Medical PMA for the TherOx System, which provides supersaturated oxygen (SSO2) therapy to reduce heart muscle damage in “widowmaker” heart attack patients. Zoll says the device delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization through angioplasty and stenting
Devices
Battelle has announced an emergency use authorization for its Critical Care Decontamination System for decontaminating respirator masks. It says each device system is capable of decontaminating up to 80,000 respirator masks per day using concentrated, vapor phase hydrogen peroxide. The masks are exposed to the validated concentration level for
Devices
FDA has released a guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.” The document provides the Center’s interpretation of key provisions in the regulation that pertain to requests for appeals of significant decisions on PMAs, 510(k)s, IDEs, and clinical
Devices
FDA has posted “Frequently Asked Questions on 3D Printing of Medical Devices, Accessories, Components, and Parts During the Covid-19 Pandemic.” The document provides the agency’s current thinking for those intending to use 3D printing to assist in meeting demand for certain products during the Covid-19 pandemic. FDA
Devices
FDA has issued an emergency use authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories to provide more needed devices for use in healthcare settings. The authorization covers devices that are not
Devices
FDA has authorized Pear Therapeutics’ Somryst nine-week prescription digital therapeutic to treat patients age 22 and older with chronic insomnia. Pear says it is the first product submitted through FDA’s 510(k) pathway and simultaneously reviewed through the agency’s software precertification pilot program. Somryst reportedly can be
Devices
FDA says that digital health technologies can provide tools for public health officials and the public to use in managing the Covid-19 response by helping public health officials reach and communicate with a vast number of people more quickly, efficiently, and effectively. An online post says the agency does
Devices
FDA has extended the comment period on a 2/25-26 public workshop on the “Evolving Role of Artificial Intelligence in Radiological Imaging.” Comments can be submitted until 6/30, according to an agency notice.