Devices
FDA inspections at two Olympus medical device manufacturing facilities in Japan led to separate Warning Letters. A just-released 12/12/22 Warning Letter was issued to Olympus Medical Systems Corp. following a 9/6-9/9/22 inspection at the firm’s Tokyo, Japan, facility that manufactures gastrointestinal and
Devices
FDA has released a draft guidance entitled “Photobiomodulation (PBM) Devices — Premarket Notification 510(k) Submissions.” The document provides draft recommendations for 510(k) submissions for PBM devices (also known as low level light therapy devices), which are intended for use in applications such as esthetics, dermatology, and other general indications.
Devices
An FDA Office of Criminal Investigations probe has resulted in guilty pleas by Jennifer Robertson (Battle Creek, MI) and Michelle McAllister (Jerome, MI) over their participation in a multi-year, interstate conspiracy to transport and traffic diabetic test strips stolen from the Battle Creek Veterans Affairs Medical Center. The test
Devices
Researchers from several academic medical centers say that among 156 medical devices cleared through the 510(k) pathway and subject to a Class 1 recall from 2017 through 2021, 44.1% were authorized using predicates that were also subject to Class 1 recalls. Devices authorized using these predicates were 6.
Drugs
A SheppardMullin report on “2023 Top-of-Mind Issues for Life Sciences Companies” looks at several FDA issues as well as other federal agencies. In 2022, the report says, the CDER Office of Prescription Drug Promotion (OPDP) continued its downward trend in enforcement, issuing just one Warning Letter and three
Devices
Two artificial intelligence (AI) experts writing in a Stat News opinion column say there are four areas in which bias can enter an algorithm used in medicine that should be addressed by FDA. Gesund CEO Enes Hosgor and radiologist Oguz Akin say the four areas that can skew the performance
Devices
FDA says it is partnering with Health Canada on an eSTAR pilot to test the use of a single eSTAR submitted to both agencies. An FDA notice describes eSTAR as an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. It says eSTAR
Devices
AdvaMed is making several recommendations to FDA in response to the agency’s public workshop on the appropriate use of consensus standards. The advocacy organization recommends that FDA: * issue a clear policy statement of a default three-year transition period for standards; * establish an e-mail list serve to notify
Devices
FDA has cleared a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rate, and oxygen saturation of arterial hemoglobin. During 2023, the company says it plans to submit additional data to the agency to support additional intended uses. “Motion
Devices
Zyno Medical has agreed to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare involving the intravenous (IV) administration of medication using the firm’s defective IV administration sets. The settlement resolves allegations that Zyno knowingly distributed defective
Devices
The recently signed omnibus legislation contains language to extend a drug company safe harbor to medical device companies on sharing health care economic information to formulary committees and other similar entities prior to receiving FDA approval or clearance. The legislation basically codifies a 2018 FDA guidance on the topic, “providing
Drugs
FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer, or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib). A
Devices
Washington Legal Foundation is asking the Supreme Court to review and overturn a California Court of Appeal decision that imposed $300 million in civil penalties on Johnson & Johnson’s Ethicon unit for marketing its pelvic mesh product in the state. WLF says (includes a link to the amicus brief)
Devices
The Department of Justice says Pennsylvania-based Jet Medical will pay $200,000 to resolve criminal allegations relating to a medical device migraine headache treatment, and Jet and two related companies will pay another $545,000 in a civil settlement involving the same device. A department statement says the federal
Devices
FDA says the 10/27/22 recall by Teleflex and Arrow International of the Arrow MAC Central Venous Access and Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter kits is Class 1. An FDA notice says the 1,355 recalled units were distributed 3/8/22 to
Devices
FDA says the Arrow International 10/17/22 recall of 2,132 intra-aortic balloon pumps is Class 1. An agency statement says the pumps are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications
Devices
FDA has cleared a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea (OSA) and snoring in adults. The company says the device offers a new treatment regimen that “opens the airway by expanding the palate and training the tongue to rest in proper position
Drugs
The Federal Trade Commission (FTC) has released its new “FTC Health-Related Advertising Guide” that covers more stringent compliance factors than previously expected that industry should consider before publishing health product marketing (online or offline) advertisements. Attorney Phyllis Marcus (Hunton Andrews Kurth) writes in an online post that the FTC
Devices
A 6/17/22-7/5/22 attempted FDA inspection at RoyalVibe Health, The Woodlands, TX, determined that the firm manufactures, markets, and distributes several medical devices and associated software and apps. A just-released 11/18/22 Warning Letter says the company does not have an approved PMA or
Devices
FDA says it has updated the CDRH Recognized Consensus Standards database. An agency notice says the so-called List 59 update includes new standards and new versions of recognized standards plus revisions to some standards’ extent of recognition and an extension of the transition period for two standards. FDA says
Devices
Attorneys Jeffrey Gibbs and Sara Koblitz (Hyman, Phelps & McNamara) say FDA lobbied to have language included in the appropriations bill for FY 2023 to reverse, at least in part, some of the agency’s recent court losses. Language the agency was seeking is part of the omnibus spending bill
Devices
FDA says two issues appeared at the end of 2022 in certain reworked Philips Respironics Trilogy 100 and 200 ventilators. An agency statement says those ventilators were recalled in 6/2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. It says the latest issues are: