Devices
A 2/3-2/12 FDA inspection at Lymol Medical, Woburn, MA, found Quality System Regulation violations in the firm’s manufacturing of Elite X Class rigid bronchoscope systems and Premier S Class silicone stents. A just-released 4/7 Warning Letter says specific violations were: * failing to validate according
Devices
FDA has granted an emergency use authorization (EUA) for Everlywell’s at-home sample collection kit that can then be sent to specified laboratories for Covid-19 diagnostic testing. The Everlywell Covid-19 Test Home Collection Kit is authorized to be used by individuals at home to collect a nasal
Devices
FDA has issued an alert about preliminary data from New York University researchers suggesting potential inaccurate results (false negatives) from Abbott’s ID NOW point-of-care test used to diagnose Covid-19. Abbott’s test is frequently used at the White House to test visitors before entering the Oval
Drugs
A Democratic-introduced bill this week contains several provisions affecting FDA that, even though the bill is expected to stall, are likely to be under consideration in the next coronavirus package with which the House and Senate come to terms, according to the Alliance for a Stronger FDA. The Trump
Devices
FDA has posted a new Web resource page on thermal imaging systems, also known as infrared thermographic systems or thermal imaging cameras. The page specifically discusses thermal imaging systems and Covid-19, saying that scientific studies support that certain telethermographic systems may be used to measure surface skin temperature. “When
Devices
A 1/27-2/3 FDA inspection at Ideal Implant Inc., a Dallas, TX, manufacturer of the Ideal Implant saline-filled breast implant, identified Quality System Regulation and Medical Device Reporting violations. A 5/14 Warning Letter says specific violations were: * failing to maintain complaint files and to establish and
Devices
FDA says that Allergan is not meeting the post-approval study requirements associated with its Natrelle silicone-filled breast implants (round responsive implants) and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. A 5/14 Warning Letter says the studies were required to provide information on the long-
Devices
New York University (NYU) researchers say Abbott Laboratories’ ID Now Covid-19 rapid test missed a third of the samples detected positive by Cepheid’s Xpert Xpress SARS-CoV-2 test. Abbott’s test is frequently used at the White House to test visitors before entering the Oval Office. A
Devices
CDRH Office of In Vitro Diagnostics policy analyst Allen Hill says the 510(k) third-party review program explained in a 3/12 guidance enhances quality in several ways. Speaking during a 4/16 Webinar on the guidance, Hill said the quality enhancements are that the agency has the right
Devices
FDA has cleared a Royal Philips 510(k) for ultrasound options for managing Covid-19-related lung and cardiac complications. “Handheld and portable ultrasound solutions in particular have become valuable tools for clinicians treating Covid-19 patients due to their imaging capabilities, portability and ease of disinfection,” the company says.
Drugs
FDA has added content to the question-and-answer appendix in its guidance on conducting medical product clinical trials during the Covid-19 public health emergency. An online notice says the guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video
Devices
FDA says an Applied Medical 10/24/19 recall of Python Embolectomy, BARD Embolecomy, and OTW Latis cleaning catheters due to the risk of separation during use is a Class 1 recall. A notice says 19,400 recalled units were manufactured between 7/23/15 and 11/8/18 and
Drugs
FDA commissioner Stephen Hahn says that while an agency moratorium on on-site domestic and foreign facility inspections remains in place, the agency is working with the Centers on Disease Control “to develop a process that would govern how and where to return to on-site facility surveillance inspections in
Devices
FDA has issued the first emergency use authorization (EUA) for a Covid-19 antigen test. Quidel’s Sofia 2 SARS Antigen FIA diagnostic test is designed to quickly detect protein fragments found on or within the virus by testing samples collected from the nasal cavity using swabs, according to an
Devices
Singlera Genomics says it has completed a pre-submission meeting with CDRH’s Office of In Vitro Diagnostics and it was provided clear guidance on the regulatory pathway and clinical trial plan for the Singlera Genomics ColonES assay. The test is being developed as a blood-based screening assay for
Devices
FDA has granted Rutgers Clinical Genomics Laboratory an emergency use authorization (EUA) for the first diagnostic test with the option of using home-collected saliva samples for Covid-19 testing. The laboratory developed test can process samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000
Drugs
Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA) have written FDA asking how the agency is tracking the use, safety, and effectiveness of scores of products on the market under emergency use authorizations (EUAs). Since 2/4, FDA has issued 112 EUAs for Covid-19-related medical products,
Devices
FDA has posted summarized performance data for 12 antibody (serology) tests that have been granted emergency use authorizations (EUA) for detecting the body’s immune response to the Covid-19 infection caused by the virus. About 200 serology tests had been allowed on the market without an EUA, and FDA
Devices
FDA says it is concerned that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection to health care personnel exposed to Covid-19 based on filtration performance testing conducted by CDC’s National Institute for Occupational Safety and Health (NIOSH). Because of the concerns, the
Devices
FDA says it has become aware of the potential for healthcare facility staff that reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of the devices because there is no standard color to indicate a sterilized device. An agency online notice says that the 3M
Devices
FDA has approved the Grifols Procelix Panther System for use with several U.S. licensed Procelix assays. The company says Panther uses automation ready technology (ART) that features significant hardware and software improvements that support blood-banking operations of all sizes, such as instrument networkability and information sharing. “ART supports
Drugs
A whistleblower report by ousted Biomedical Advanced Research and Development Authority (BARDA) director Rick Bright details the roles of senior FDA officials involved in allowing the broader use of malaria drugs chloroquine and hydroxychloroquine during the Covid-19 pandemic. Bright says he filed the complaint after being removed from his