Devices
FDA has granted Beckman Coulter an emergency use authorization for its Access SARS-CoV-2 Immunoglobulin M (IgM) assay. The test detects antibodies that recognize the receptor binding domain of the spike protein which the Covid-19 virus uses to enter the human host cells, the company says. The qualitative
Drugs
An online post from Govzilla, data intelligence consultants, gives tips for regulated companies on how to talk with FDA officials and how to listen when FDA officials talk to them. The post is based on information presented at a 9/2019 Regulatory Affairs Professionals Society meeting by former FDA team
Devices
CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel told the agency’s weekly virtual town hall session 10/7 that FDA will no longer review Covid emergency use authorization (EUA) submissions for lab-developed tests. Modern Healthcare reports that Stenzel said the change is consistent with
Devices
FDA has given GenMark Diagnostics an Emergency Use Authorization for its ePlex Respiratory Pathogen Panel 2. The test provides in less than two hours results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including Covid-19, flu, bronchitis and the common cold, according
Devices
FDA says Battelle Memorial Institute, Columbus, OH, failed to meet medical device reporting (MDR) requirements included in an emergency use authorization (EUA) for its Battelle Critical Care Contamination System. The system is used for decontaminating certain N95 respirators for reuse by healthcare personnel where there are insufficient supplies of filtering
Devices
The three leading Democrats on the House Energy and Commerce Committee say a new HHS policy to allow marketing of laboratory-developed tests (LDTs) without FDA review “could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect Covid-19. In
Devices
FDA has approved Biosense Webster’s Thermocool SmartTouch SF Ablation Catheter for treating persistent atrial fibrillation (AF). Approval is based on data from the PRECEPT study which met primary safety and effectiveness endpoints and demonstrated that 80% of persistent AF patients experienced clinical success at 15 months after ablation therapy
Devices
FDA says it is seeking volunteers to participate in a pilot program for the electronic delivery of premarket submissions. The pilot is to provide an alternate method to submit a medical device premarket submission for 90 days during the Covid-19 pandemic. An agency online notice says the pilot’s
Devices
Senseonics Holdings has submitted a PMA supplement seeking to extend the wearable life of the Eversense Continuous Glucose Monitoring System from 90 to 180 days. The submission was based on data from the PROMISE clinical study. The 181-patient trial had participants have the Eversense sensor inserted subcutaneously at eight
Devices
FDA has classified as Class 1 a recall of Becton Dickinson’s Alaris Pump Module and Pump Module Door Assembly Replacement Kits because the keypad may have one or more keys that become unresponsive or stuck. The infusion pump module delivers fluids, medications, blood and blood products into a patient’
Devices
FDA has updated its information Web page about eligibility for its Voluntary Malfunction Summary Reporting program. The program allows manufacturers to report certain device malfunction Medical Device Reports in summary form on a quarterly basis. The updated information is related to: * How to identify a device product code eligible for
Drugs
The Massachusetts federal court allowed misdemeanor convictions to stand in an off-label promotion case but said “it seems clear that the statutory and regulatory scheme needs to be re-thought.” Attorney Stephen McConnell (Reed Smith) writes online in a Drug and Device Law Blog post that the judge pointed
Devices
FDA says it has updated the SARS-CoV-2 reference panel comparative data on the agency Web site to reflect the latest information. The panel is described as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The agency
Devices
FDA says its ongoing evaluation of the risk of Nontuberculosis mycobacteria (NTM) infections in patients who undergo cardiothoracic surgery using heater-cooler devices has found three U.S. patients from one facility who were infected with Mycobacterium abcessus (a type of NTM) after undergoing cardiothoracic surgery involving the use of
Devices
FDA has published a guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, with recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The document says the agency is issuing it to help ensure that a patient receives and understands
Devices
FDA has published a guidance, Breast Implants—Certain Labeling Recommendations to Improve Patient Communication, with recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The document says the agency is issuing it to help ensure that a patient receives and understands
Devices
FDA has issued Assure Tech an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for Covid-19. The Assure Covid-19 IgG/IgM Rapid Test Device was first authorized for emergency use in July and the EUA is now being reissued for the POC
Devices
FDA is issuing three guidances finalizing the Accreditation Scheme for Conformity Assessment (ASCA) program. An agency Webinar on the guidances is set for 10/22, according to an online notice. The guidances are: * The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program says FDA believes the voluntary ASCA pilot may
Devices
FDA has released the FDA-483 issued following a 3/16-3/20 inspection at Front Range Laboratories, Loveland, CO. The three inspection observations were: * failing to establish the accuracy, specificity, and reproducibility of test methods; * failing to establish and write procedures designed to prevent microbiological contamination of drug products
Devices
FDA has issued updated recommendations saying that individuals who are part of seven groups thought to be at greater risk for potential harmful health effects of mercury vapor released from amalgam dental fillings should avoid getting dental amalgam whenever possible and appropriate. An agency statement identifies the high-risk groups
Devices
A coalition of 49 attorneys general have announced a multistate agreement that requires C.R. Bard and its parent company, Becton, Dickinson, to pay $60 million for the “deceptive marketing of transvaginal surgical mesh devices that endangered the health of women across New York and the rest of the nation,
Devices
FDA is launching a Digital Health Center of Excellence within CDRH. An online announcement says the launch “is an important step in furthering the agency’s overarching dedication to the advancement of digital health technology, including mobile health devices, software as a medical device, wearables when used as a medical