Devices
FDA has recognized the ANSI National Accreditation Board (ANAB) as an accreditation body for the Accreditation Scheme for Community Assessment (ASCA) pilot. ANSI (the American National Standards Institute) says the agency recognition allows ANAB to accredit testing laboratories to perform premarket testing for medical device companies. The ASCA pilot relies
Devices
FDA has released a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on artificial intelligence and machine learning (AI/ML) in medical devices. The transcript notes the committee discussed the composition of the datasets on which the software “learns,” components of the
Drugs
Johnson & Johnson (J&J) subsidiary Medical Device Business Services has agreed to pay $10 million to settle allegations under the False Claims Act that former J&J subsidiary Therakos promoted Uvar XTS and Cellex extracorporeal photopheresis systems for unapproved uses in pediatric patients between 2006 and 2012.
Drugs
The Stericycle Recall Insights report for the third quarter of 2020 shows that drug recalls increased markedly in the quarter while medical device recalls fell to their lowest level in several quarters. The report says that drug recall activity increased by 49.5% in the third quarter, with affected units
Devices
FDA has approved Armis Biopharma’s VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. The company says the device is designed to make such surgical corrections more accessible to patients through shorter time
Devices
FDA has cleared an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and colonoscopes. The device is labeled for sterilizing reusable medical devices that are sensitive to moisture, heat, corrosion or radiation, the company says. It was originally cleared in
Drugs
The HHS Office of Inspector General (OIG) says it has significant concerns about companies offering or paying remuneration, and healthcare professionals (HCP) soliciting or receiving remuneration, in connection with speaker programs. “Based on our investigations and enforcement actions,” an OIG fraud alert says, “this remuneration is often offered or paid
Devices
Sens. Charles Grassley (R-IA) and Elizabeth Warren (D-MA) have asked FDA to issue its proposed rule on over-the-counter hearing aids as quickly as possible. In an 11/13 letter, the senators say that since President Donald Trump signed the Over-the-Counter Hearing Aid Act into
Devices
FDA says its review of data and information from several sources indicates that there generally are more benefits than risks to patient safety and health related to software functions excluded by the 21st Century Cures Act from the definition of a medical device. The agency’s 2020 report on risks
Devices
Federal Register notice: FDA has made available a draft guidance entitled Electromagnetic Compatibility of Medical Devices. The document describes relevant information that should be provided in device premarket submissions. To view the notice, click here.
Devices
A 10/22 CDRH Webinar provided background information and an overview of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. In the presentation, CDRH Standards and Conformity Assessment Program senior policy analyst Stacy Cho said that during the MDUFA 4 reauthorization negotiations, FDA and industry agreed to establish a
Devices
FDA has made available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices. The document provides recommendations about information that should be provided in medical device submissions to demonstrate the EMC for electrically powered devices with electrical or electronic functions. The agency says that typically the review of EMC
Devices
FDA has granted 510(k) clearance for the use of Lantheus’ artificial intelligence-enabled automated bone scan index product on the GE Healthcare Xelerix platform. The company describes it as a vendor-neutral standalone software as a medical device that calculates the automated bone scan index in Technetium-99m bone
Devices
Members of the FDA Ophthalmic Devices Panel voted 11/9 to recommend against approval of the Refocus Group’s VisAbility Micro Insert System with a proposed indication for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between 45 and 60 years old with specified manifest spherical
Devices
FDA says the Cook Medical 10/14 recall of its fixed core wire guide is Class 1. An agency statement says Cook recalled the product because five lots of wire guides dropped onto an unchecked surface during production. The notice said the drop could cause the wire guide to bend
Devices
Beyond Air says it has submitted a PMA application to FDA for its LungFit PH to treat persistent pulmonary hypertension of the newborn. A company statement describes LungFit as a cylinder-free, plastic flow nitric oxide generator and delivery system that could potentially replace large, high-pressure nitric oxide cylinders,
Devices
NightWare says FDA has given marketing permission through the de novo pathway for the company’s NightWare therapeutic platform that is the only medical device to be indicated for the temporary reduction of sleep disturbances related to nightmares in adults age 22 and older who suffer from nightmare disorder or
Devices
FDA says the 9/21 Stryker Neurovascular recall of its Trevo XP ProVue Retriever due to a core wire issue is Class 1. The device is intended to restore blood flow or remove blood clots within a blood vessel in the brain during an acute ischemic stroke. An agency recall
Devices
FDA has issued a final guidance on Regulatory Considerations for Microneedling Products. The document is intended to assist industry in understanding when a microneedling product is a device for regulatory purposes. It also provides information on the regulatory pathway to market for microneedling devices for esthetic use. According to the
Devices
FDA is implementing a certification program for medical devices not exported from the U.S., which is mandated under the Coronavirus Aid, Relief, and Economic Security Act. If certain requirements are met, a Certificate for Device Not Exported from the U.S. (CDNE) may be issued upon request, an agency
Devices
The Covid-19 emergency has had the unintended consequence of cementing the use of real-world evidence (RWE)and real-world data (RWD) in product submissions at FDA. Writing in a Med Device Online 11/4 article, Hogan Lovells attorneys Kelliann Payne, Blake Wilson, and Megana Sankaran predict RWE will
Devices
Researchers from Yale University and several other academic centers say that in their study, a large proportion of first-time implantations of cardioverter-defibrillator ICD) and cardiac resynchronization therapy-defibrillators (CRT-D) were performed by doctors who received payments from medical device manufacturers. “Patients were more likely to receive ICD