Devices
During the 4/28 MDUFA 5 user fee negotiating session, industry representatives presented their overall proposal for the MDUFA 5 package. Just-released minutes of the session say the industry first confirmed its principles for the user fee program: * supporting timely patient access to safe and effective medical devices and
Devices
FDA has accepted the first preclinical module submitted by Invivo for its humanitarian device exemption (HDE) application for the Neuro-Spinal Scaffold implant. The company says the remaining modules cover manufacturing and clinical data. All three must be accepted before an agency final approval decision. Invivo says it is currently
Devices
Magellan Diagnostics has recalled its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of false low results. “The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such
Devices
Avanos Medical has agreed to pay more than $22 million to resolve a criminal charge relating to the company’s fraudulent misbranding of its MicroCool surgical gowns. According to the Justice Department, Avanos falsely labeled the gowns as providing the highest level of protection against fluid and virus penetration. Additionally,
Devices
FDA has announced an 11/12 virtual public workshop on orthopedic cartilage repair products. The workshop is intended to provide manufacturers, regulatory affairs professionals, clinicians, patients and the general public a forum to share information about data and studies needed to support marketing submissions for such products. To register for
Devices
St. Jude Medical has agreed to pay $27 million to settle allegations under the False Claims Act that it knowingly sold defective heart devices to health care facilities. “The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information
Devices
FDA is warning health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The implants are intended for people age 18 years and over to lengthen a limb, shorten or compress a limb, or transport segments of long bones. An
Devices
Alere Inc. and its Alere San Diego subsidiary will pay $38.75 million to resolve federal government allegations that they violated the False Claims Act by billing Medicare for defective rapid point-of-care testing devices. A Department of Justice statement says the government alleges that between 2008 and 2018
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FDA says a Quidel 4/26 recall of specified lots of its Lyra SARS-CoV-2 assay due to a significant risk of false-negative results for patients with relatively high amounts of SARS-CoV-2 virus potentially causing the PCR (polymerase chain reaction) amplification to occur before a cycle-
Devices
FDA has cleared an AliveCor 510(k) to use its KardiaMobile 6L device to calculate patients’ QTc interval. The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system, the company says. “QT prolongation can stem from congenital long QT syndrome, many
Devices
FDA has granted Hyalex Orthopedics a breakthrough device designation for the Hyalex Cartilage System, intended for use in repairing cartilage defects and restoring function for patients with loss of knee articular cartilage and bone requiring surgery. The device’s biomimetic material properties create the potential to replace a damaged joint
Devices
FDA has cleared the UVision 360 Luminelle Bx (biopsy) sheath, expanding the capability of the Luminelle DTx system. The company says the sheath, combined with the DTx system, is the first and only integrated directed biopsy device not requiring the use of additional instruments and indicated for uterine and bladder
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Magnetom Free Max, a new High-V magnetic resonance scanner. The company says the device combines a 0.55 Tesla field strength with deep learning technologies and advanced image processing. It is the first 80 cm wide-bore system available,
Devices
FDA says in response to an increased availability of domestically-manufactured NIOSH (National Institute of Occupational Safety and Health)-approved N95 disposable respirators, it is revoking the emergency use authorizations (EUAs) of all non-NIOSH-approved disposable respirators, such as KN95s, along with the EUAs for decontamination and bioburden reduction
Devices
FDA has released a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The document is intended to assist labelers and FDA-accredited issuing agencies in complying with UDI labeling requirements. It describes requirements on UDI form and content to help ensure that
Devices
The U.S. Court of Appeals for the District of Columbia has vacated an FDA rule that determined that electrical stimulation devices used to treat aggressive or self-injurious behavior present an unreasonable and substantial risk of illness or injury, but only when used to treat aggressive or self-injurious
Devices
FDA says Aquavit Pharmaceuticals is marketing the Aquagold and Advanced Skin Application Platform micro infusion system in the U.S. without marketing clearance or approval. A 6/17 Warning Letter says the products are devices because they are intended for use in the diagnosis of disease or other conditions or
Devices
Avid Medical has recalled (Class 1) medical convenience kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk of contamination with Aspergillus penicillioides. Contaminated kits could cause serious systemic infection, sepsis, illness, and death to a patient, a recall notice says. “If the fungus is introduced in
Devices
FDA has approved an Oticon Medical PMA for the company’s Neuro System to treat individuals 18 years or older with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aids. The device is the first cochlear implant system to be approved in more
Devices
FDA has released the FDA-483 issued following a 1/13-1/16 inspection at Venus Concept, a San Jose, CA, manufacturer. The two inspection observations were: * failing to adequately document corrective and preventive action activities and/or results; and * failing to adequately maintain complaint files.
Devices
The HHS Inspector General (IG) says FDA should be working with the Centers for Medicare and Medicaid Services (CMS) on cybersecurity for networked medical devices in hospitals. In an Issue Brief, the IG says that without proper cybersecurity controls, hospitals’ networked medical devices can be compromised, which can lead to
Devices
At the 4/7 MDUFA 5 reauthorization meeting, FDA presented its initial proposal for a total product lifecycle (TPLC) advisory program (TAP). According to meeting minutes, the agency said the current MDUFA program has been optimizing a limited portion of the TPLC. “By investing in earlier and more strategic coordination