Devices
FDA says it has sent Warning Letters to three companies for marketing adulterated and misbranded Covid-19 antibody tests. An agency notice says the letters went to Mediakit Ltd., Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus and Sunrise Family Dental, doing business as My
Devices
FDA has announced a 9/30 virtual public meeting entitled “Patient-Reported Outcomes (PROs) and Medical Device Investigations: From Conception to Implementation.” The meeting is intended to discuss the benefits and challenges of incorporating patient perspectives in regulatory decision making using PRO instruments. The meeting is part of CDRH’s
Devices
A 2/10-2/25 FDA inspection at Klarity Medical Products, Newark, OH, found multiple violations related to the firm’s work as a specification developer and manufacturer of various body support devices used during patient radiation therapy treatment. A 6/8 Warning Letter says the Klarity BiteLok device is
Devices
Endologix has recalled the Ovation iX Abdominal Stent Graft System due to risks of liquid polymer leaks during implantation. In 2018, the company issued an important safety update about the leaks which it then said were due to incorrect use of the device. Now, the recall is clarifying that the
Devices
FDA has approved Allergan Aesthetics’ Juvéderm Voluma XC for the augmentation of the chin region in adults over the age of 21. The approval marks the second indication for the product, which was previously approved in 2013 for cheek augmentation to correct age-related mid-face volume deficit. The approval
Devices
FDA has cleared a Canon Medical 510(k) for the compressed Speeder technology for the company’s Vantage Orian 1.5T MRI system that is intended to speed up MRI scan times by reconstructing full resolution images from under-sampled data through iterative reconstruction. The faster throughput allows for substantial
Devices
FDA has posted a “question and answer” Web page to address adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of Covid-19-related guidance documents. The page also points out a number of adverse event reporting-related resources. Under FDA’s
Devices
An FDA grant and a philanthropic gift from Mei Xu, founder of e-commerce platform Yes She May, will fund the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), a product development competition focused on Covid-19-related pediatric medical devices that support home health monitoring and telehealth diagnosing
Devices
FDA says it will host a virtual town hall on 6/17 from 12:15 to 1:15 pm EDST for clinical laboratories and commercial manufacturers that are developing or have developed SARS-CoV-2 diagnostic tests. An agency notice says the meeting is to help answer technical questions about
Devices
FDA has issued an emergency use authorization to Illumina, Inc., for the first Covid-19 diagnostic test using next-generation sequencing technology. An agency statement says FDA authorized the Illumina COVIDSeq test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of Covid-
Devices
FDA says that all radiation safety reports may now be submitted to CDRH by email to the [email protected] mailbox. These include all report types, such as product reports, annual reports, and supplemental reports of all types, and all communications such as notifications of defect/failure to comply,
Devices
FDA has cleared an Atomic Blue 510(k) for its high-performance UV-C germicidal light for commercial use in eradicating the Covid-19 virus from surfaces. The device has been registered with the agency as a disinfectant medical device with the product code LRJ. “When biological organisms are exposed
Devices
FDA has cleared a Sekisui Diagnostics 510(k) for the Osom Ultra Plus Flu A&B Test and its use in the qualitative detection of influenza Type A and Type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.
Drugs
Six Hogan Lovells attorneys say the 6/4 FDA update to the Compliance Program Guidance Manual (CPGM) includes a program for inspecting CDER-led and CDRH-led combination products. In an online post, the attorneys write that the updated manual says it “focuses on inspections of combination product manufacturers of
Devices
FDA has posted test performance data from four antibody, or serology, test kits from an independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The data are among the first to come from a collaborative effort by FDA, NIH, Centers for Disease
Devices
FDA has reissued certain emergency use authorizations (EUAs) to identify specific respirators that can be decontaminated for reuse. “Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel,
Devices
FDA has approved an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Cardiac Power (ECP) heart pump. The device will be studied in high-risk percutaneous coronary intervention (PCI) patients, the company says. Impella ECP is the world’
Devices
FDA has posted a revised guidance entitled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The revision is intended to articulate agency policy to help expand the availability and capability of non-invasive remote monitoring
Devices
FDA has cleared a Transit Scientific 510(k) for its XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic or native arteriovenous hemodialysis fistula procedures. Angioplasty is performed with expandable polymer balloon catheters to dilate stenosed,
Devices
FDA has issued a PowerPoint presentation, Testing Supply Substitution Strategies, describing a new Web resource for labs performing Covid-19 tests that are authorized. The slide show says the resource includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some
Drugs
FDA has issued a compliance guide for inspections of CDER-led or CDRH-led combination products. The document says that a single establishment inspection report and, where applicable, FDA-483 should be used to document all observations made during an inspection at a combination product manufacturer. The guide’s contents
Drugs
FDA has issued an immediately-in-effect guidance, FDA Guidance on Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency, to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial