Devices
FDA has given 510(k) clearance to the BioMérieux Vitek MS Prime, its new MALDI-TOF mass spectrometry identification system. The company says it is a next-generation system for routine microbial identification in minutes. BioMérieux describes the Vitek MS Prime as “a compact benchtop system designed to increase laboratory
Devices
An FDA safety communication alerts people that there is a potential for harm if authorized at-home Covid-19 tests are not used according to the manufacturer’s test instructions. The online document also reminds people to keep the tests out of reach of children and pets. “Incorrect use of
Devices
FDA has granted an emergency use authorization for an Indicaid Covid-19 over-the-counter at-home rapid antigen test. An agency statement (contains a link to the emergency authorization document) says the test delivers results in 20 minutes. The test can be used as (1) a single test for
Drugs
FDA is planning several pilot programs to test ways to improve foreign inspections, agency staff have told Bloomberg Law. For an online story, Bloomberg talked to several attorneys about the foreign inspection program and the need for improvements. The attorneys said that increasing agency staff, using unannounced inspections, and hiring
Devices
University of California San Francisco researchers say that since the implementation of the 21st Century Cures Act, which directed FDA to consider the role of post-market information in determining the least burdensome means for approval, there has been no significant increase in the frequency of FDA post-approval study
Devices
FDA says a Celltrion USA 2/28 recall of its Celltrion DiaTrust Covid-19 Ag Rapid Test is Class 1. Some 45,500 units that were distributed between 6/2 and 12/21/21 were recalled due to a high number of false-positive reports for some tests, an agency
Devices
FDA has cleared a Niramai Health Analytix 510(k) for its SMILE-100 System, a breast thermography device that is intended to help healthcare professionals review, measure and analyze thermally significant areas in the breast region. The device, which is designed to be used in the hospital, acute care settings,
Devices
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910-0131). Under FDA regulations, nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized
Devices
A 9/28-10/6/21 FDA inspection at the NeuroField medical device operation in Bishop, CA, found multiple violations in the firm’s manufacturing of neurostimulation and electroencephalogram signal processing devices and software products. A 2/28 Warning Letter says the firm’s devices are adulterated because the company
Devices
FDA has classified as Class 1 a LuSys Laboratories recall of its Covid-19 antigen tests (nasal/saliva) and Covid-19 IgG/IgM antibody tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S.
Devices
FDA has classified as Class 1 a Baxter Healthcare recall of its Sigma Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of the devices not sounding alarms for repeated upstream occlusion events. The
Devices
FDA has issued a warning against using Apyx Medical’s Renuvion/J-Plasma device for certain aesthetic procedures, such as procedures intended to improve the appearance of the skin through dermal resurfacing or skin contraction. The device is cleared for general use of cutting, coagulation, and ablation of soft tissue
Devices
FDA has issued a warning against using ACON Biotech Covid-19 tests. The agency says the China-made tests are labeled “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” and packaged in a dark blue box. This test has not been authorized, cleared, or approved for distribution or use
Devices
FDA has issued a rare Section 518(a) notification order to Philips Respironics “requiring the company to notify patients and others of the company’s 6/14/2021 recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk
Drugs
The House Energy and Commerce Committee Health Subcommittee has announced a 3/17 hearing entitled “The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight.” The hearing will discuss various draft legislative proposals to revamp FDA’s approval and oversight of medical products, among other issues. For example, the
Devices
FDA has cleared a NeuroLogica (a subsidiary of Samsung Electronics) 510(k) for the addition of Photon Counting Detector (PCD) technology to its OmniTom Elite 16-slice computed tomography (CT) scanner. OmniTom Elite with PCD can generate spectral CT images at multiple energy levels, the company says. “Photon counting is
Devices
Medtronic has recalled its TurboHawk Plus Directional Atherectomy System, which comprises a catheter and a cutter driver, because it is similarly designed as the company’s HawkOne Directional Atherectomy System, which was recently recalled for a correction. The device is used during procedures intended to remove a blockage from peripheral
Devices
The Regulatory Affairs Professional Society (RAPS) says FDA and the medical device industry have reached an agreement on the MDUFA 5 user fee program that will bring the agency $1.784 billion in user fees over the next five years. The total reportedly could grow to $1.9 billion if
Devices
FDA has cleared a Cionic 510(k) for its lightweight leg-worn Cionic Neural Sleeve, intended for functional electrical stimulation to assist in gait for people with foot drop and leg muscle weakness. It is designed to help people with mobility issues due to multiple sclerosis, stroke, cerebral palsy, and
Devices
Former FDAer Ryan Foringer has joined Hogan Lovell’s medical device and technology practice as a senior regulatory specialist. In his four years at the agency, Foringer was a consumer safety officer in the Center for Food Safety and Applied Nutrition, a lead reviewer and chemical engineer in the CDRH
Devices
An 8/19-9/17/21 FDA inspection at CardioQuip, College Station, TX, found Quality System Regulation and other issues in the firm’s manufacturing of a cardiac heater-cooler product in various configurations. A just-released 2/11 Warning Letter says the firm holds an 11/19/2010 510(
Drugs
The National Academies Committee on Security of America’s Medical Product Supply Chain makes seven recommendations for FDA, other government agencies, and other stakeholders to take to increase the resilience of the medical product supply chain. In a report (purchase or free PDF download) mandated by the 2020 CARES Act,