Devices
FDA late 3/25 issued an immediately-in-effect guidance: Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. The agency said it “believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand
Drugs
FDA says funds are available for projects to support the agency’s understanding of the potential use of real-world data (RWD) to generate real-world evidence (RWE). An online announcement says FDA is particularly interested in projects that compare the use of RWD and generation of RWE with more
Devices
FDA has cleared an Align Technology 510(k) for the iTero Element 5D Imaging System. The intraoral scanner features near-infrared imaging technology to scan the internal structures of teeth (enamel and dentin) in real time, the company says. Its visualization tools are intended improve patient engagement and communication to
Devices
In a letter to medical device establishments, CDRH says it has taken some steps to prioritize work that advances the nation’s response during the Covid-19 national emergency. The letter says the steps “seek to address the impact of the Covid-19 public health emergency on day-to-day
Devices
To increase U.S. coronavirus supplies, FDA is now providing instructions to manufacturers importing personal protective equipment (PPE) and other devices. The instructions clarify the types of PPE that can be imported without agency interaction. It also includes advice on information importers can submit to expedite their import entries. “We
Devices
FDA has issued an emergency use authorization for Cepheid’s point-of-care coronavirus diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 test, which can provide test results within hours instead of days current testing requires. The test is for use in high- and moderate-complexity CLIA-certified laboratories as
Drugs
FDA has released a guidance entitled “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.” The document addresses the limited number of drugs that are subject to a REMS that requires laboratory testing ( e.g., liver enzyme testing) or imaging studies (e.g., magnetic resonance imaging). FDA
Devices
FDA has issued a new policy that allows manufacturers of certain FDA-cleared vital sign-measuring devices to expand their use for healthcare providers to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure. “This policy applies to certain modifications to
Drugs
FDA has issued a guidance entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.” The document discusses situations where medical product adverse event reports could be delayed due to pandemic-related high employee absenteeism. The document says that certain required submissions could be delayed provided
Devices
Unable to require medical device manufacturers to report shortages, FDA is turning to Twitter to hunt for information on coronavirus testing supplies. Politico reports that a “fundamental gap in the flow of information has made it impossible for FDA to identify weaknesses in the supply chain for coronavirus testing and
Devices
CME America has recalled its BodyGuard Microset Infusion Sets due to potential medication flow restrictions. Certain sets (catalog number A120-003XYVA) have an extended section of tubing longer than standard lengths, which can restrict medication flow to the pumping chamber of the infusion pump, according to a recall notice. (XXINSERT
Drugs
FDA has issued an immediately-effective guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products during the Covid-19 Pandemic, to help clinical trial sponsors assure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity during the Covid-19 pandemic.
Drugs
President Trump says he has asked FDA to cut through “red tape and reduce regulatory barriers,” presumably to advance products associated with the coronavirus outbreak. During a virus press briefing at the White House 3/18, Trump said: “We’re looking at some very exciting things ... some things are happening
Devices
FDA has added three questions to its Frequently Asked Questions document about the development of diagnostics for SARS-CoV-2 (generally known as coronavirus or Covid-19). The updated document includes answers to these new questions: * What laboratories are offering testing under the Policy for Diagnostic Tests for Coronavirus Disease-
FDA Policy/General
Former FDA commissioner Scott Gottlieb says the U.S. will be in good shape for coronavirus testing by the end of the week. “Well, I think we're going to see a dramatic increase in diagnostic capability this week,” he said 3/15 on CBS’s Face the Nation.
Devices
Within 24 hours of the sponsor’s request, FDA 3/13 issued the fourth coronavirus Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic. “Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of
Devices
FDA has cleared a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables “machine vision capabilities” on the Senhance Surgical System. The device is intended to assist in controlling laparoscopic instruments for “visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery,
Devices
FDA has posted Frequently Asked Questions relating to diagnostic testing for SARS-CoV-2 (popularly known as coronavirus or Covid-19). The document’s first question asks if labs that offer their test under the new FDA policy have to report all their results as presumptive. The agency answers that
Devices
FDA has cleared an Ossio 510(k) for its OssioFiber Hammertoe Fixation System for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts. The bio-integrative implant with disposable, sterile instrumentation comes in three sizes, with both straight and angled configurations for patient customization, the company
Devices
A day after FDA commissioner Stephen Hahn was criticized during a House Appropriations subcommittee hearing 3/11 about delays in testing and a lack of transparency (see story) amid the coronavirus outbreak, National Institute of Allergy and Infectious Diseases director Anthony Fauci told the House Oversight and Reform Committee that
Devices
FDA has issued a guidance, 510(k) Third Party Review Program, describing the process FDA uses to recognize qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk device eligible for review under the CDRH Third Party 510(k) (3P510k) Review Program.
Devices
In a letter to healthcare providers, FDA provides recommendations for conservation strategies that may be needed as the need for personal protective equipment such as surgical masks, surgical and isolation gowns, and surgical suits may outpace the supply available to healthcare organizations during the Covid-19 outbreak. The letter says