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
Devices
Attorneys Benjamin Zigarelli and Elizabeth Conti (Mintz) say it is unlikely that the relaxed enforcement of medical devices during the Covid-19 pandemic is likely to become permanent following the crisis. “The FDA policies reducing certain regulatory strictures clearly state that such targeted enforcement discretion is temporary and will end
Devices
FDA has cleared a HeadsafeIP 510(k) for its Nurochek system for brain assessment in patients aged 14 years and older. The portable visual evoked potential (VEP) testing system is intended for use at the point-of-care to provide an objective measure of brain function, according to the company.
Devices
FDA has issued an immediately-in-effect guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act During the Covid-19 Public Health Emergency, to implement the medical device notification requirement that was included in
Devices
A 10/28-10/31/19 FDA inspection at Bedfont Scientific, Kent, UK, found Quality System Regulation violations in the firm’s manufacturing of carbon monoxide gas analyzers. A just-released 2/12 Warning Letter lists the specific violations as: * failing to establish and maintain procedures for validating the device
Devices
FDA has revised a 3/26 guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency” to articulate changes to requirements for serology (antibody) tests. Under this revised policy (see earlier story), the agency says antibody test commercial manufacturers will need to submit emergency use authorization requests,
Devices
An 8/27-8/30/19 FDA inspection at Philosys Co. Ltd., Gunsan-si, Korea, found Medical Device Reporting (MDR) Regulation violations in the firm’s manufacturing of self-monitoring blood glucose test systems. A just-released 1/14 Warning Letter says the inspection also revealed several “nonconformances” that were
Devices
Faced with the problem of allowing about 200 Covid-19 serology (antibody) tests on the market without normal vetting or reviews, FDA 5/4 tightened expectations for antibody test developers to market such tests. Based on a lack of testing at the beginning of the pandemic, the agency had relaxed
Drugs
FDA’s moratorium on domestic and foreign inspections during the Covid-19 emergency has been extended indefinitely. In early March, FDA first postponed foreign inspection of regulated products until 5/1. Shortly thereafter, domestic inspections were postponed too. FDA spokesman Jeremy Kahn told FDA Webview 5/4 that the agency
Devices
FDA has posted a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide.” The document supports requirements published 4/1/2019 in a final rule entitled “Classification of Posterior Cervical Screw Systems.” The guide is intended to help small entities comply with the final rule on
Devices
Six Skadden Arps attorneys say that from 2014 through 2019 the Justice Department brought enforcement actions against 67 medical technology companies. The actions led to criminal and civil fines and penalties totaling more than $1.9 billion. “As federal spending on health care increases markedly in response to the Covid-
Devices
FDA has granted an emergency use authorization for a new high-pressure ventilator developed by NASA engineers for treating coronavirus patients. The device, called VITAL (Ventilator Intervention Technology Accessible Locally) was developed by engineers at NASA’s Jet Propulsion Laboratory (JPL) in California. The Office of Technology Transfer and Corporate
Devices
CME America has decided to remove from the market all recalled (Class 1) BodyGuard Infusion Pump Systems because they may under or over infuse medications. The reason for the infusion errors is not known, a recall notice says. Using an affected infusion pump may cause serious adverse health consequences including
Devices
FDA has granted marketing authorization for the Medtronic Carpediem system of continuous renal replacement therapy (CRRT) for use in pediatric patients with certain kidney conditions. An agency statement says that CRRT involves using a dialysis machine and a special filter to continuously clean a patient’s blood for an extended
Drugs
A Government Accountability Office (GAO) report says FDA and other federal agencies should be doing more to better determine the magnitude and reduce the impact of antibiotic resistance. GAO says it was asked to review federal efforts to address antibiotic resistance. Its report looked at federal efforts and challenges related
Devices
FDA has cleared a Personal Genome Diagnostics 510(k) for PGDx eliotissue complete, a diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer. The device detects single nucleotide variants and small insertions and deletions (indels) in more than 500 genes, select amplifications and translocations,
Devices
FDA has cleared a Life Spine 510(k) to market implant and instrument additions to its ARx Spinal System. The additions are intended to provide surgeons with tools to accommodate a larger range of complex and deformity spinal procedures,” the company says. The device acts as a spacer to maintain
Devices
Caris Life Sciences says it has submitted PMA applications to FDA for its MI Exome CDx and MI Transcriptome CDx. The company says the two whole transcriptome sequencing (RNA) products “are powerful precision medicine assays that include key companion diagnostic biomarkers with therapy claims, and detect all classes of alterations
Devices
FDA has issued a guidance, eCopy Program for Medical Device Submissions, to describe how the agency is implementing the eCopy Program for medical device submissions. The document says the FDA Safety and Innovation Act requires the submission of electronic copies with the issuance of this final guidance. The guidance provides
Devices
In a letter to healthcare providers, FDA says it recognizes that the need for personal protective equipment (PPE) such as surgical masks, surgical and isolation gowns, and surgical scrubs may outpace the supply available during the Covid-19 outbreak. A separate letter refers specifically to medical gloves. The gown and
Devices
The Massachusetts U.S. Attorney’s Office has announced that physician Jeffrey R. Carlson (Newport News, VA) has agreed to pay $1.75 million to resolve allegations that he accepted kickbacks from SpineFrontier, a Massachusetts-based medical device manufacturer. In March, the government filed a False Claims Act complaint against
Devices
FDA told a Congressional briefing earlier this month that it is considering tougher requirements on Covid-10 serology (antibody) tests that are currently coming on the market without normal vetting or review under the agency’s emergency use authorization (EUA) pathway. The 4/17 briefing before House Oversight Committee staff