Drugs
FDA says it intends to amend its medical product intended use regulations that describe the types of evidence relevant to determining whether a product is intended for use as a drug or medical device under the law and implementing regulations, including whether an approved or cleared medical product is intended
Devices
FDA has granted Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System. The grant follows completion of the company’s SCOUT (Spineology Clinical Outcomes Trial) study. “OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through
Devices
[Report by Jim Dickinson] Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the labeling of intrauterine devices (IUDs) implanted in an estimated 15 million American women. Most recent publicly available data show over 20,000 FDA-logged IUD
Devices
FDA has approved a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications. The device’s approval is based on clinical data demonstrating that the device “achieved superiority to the fusion control on the composite primary endpoint,” the company says. The prospective trial enrolled 166
Devices
Becton, Dickinson says four previously announced recalls of its BD Alaris System have been classified as follows: 1. Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits (Class 1 recall): The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress,
Devices
CDRH has updated its public Manufacturer and User Facility Device Experience (MAUDE) database to improve transparency and analysis of medical device report (MDR) data. The update adds details on individual events included in summary reports for device registry exemptions in “comma-separated values” format. The update also allows for analyzing
Devices
FDA has cleared a 410 Medical 510(k) for its LifeFlow device for rapid delivery of blood and blood components, in addition to its previous clearances for crystalloid and colloid resuscitative fluids. The device is intended for treating severe hemorrhage, which is a leading cause of preventable death from trauma
Devices
FDA has published comparative performance data for more than 55 authorized molecular diagnostic Covid-19 tests against a standardized sample panel provided by the agency. An FDA statement says it provided the reference panel to test developers who are required to assess their tests’ performance against the panel or other
Devices
FDA has cleared a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter. The device combines 48 ultrasound transducers responsible for creating an “anatomical geometry” and 48 engineered electrodes which enable “electrical activation patterns” to be displayed along the inner surface of the heart. “Compatible
Devices
After failing to convince FDA commissioner Stephen Hahn that the agency should give up its responsibility for evaluating the safety and accuracy of laboratory-developed Covid-19 tests, HHS secretary Alex Azar took the matter into his own hands and revoked FDA’s ability to evaluate the tests. In an
Devices
An update on the status of the FDA software precertification program indicates the evaluation of the pilot program will continue, apparently with no additional pilot participants and no indication that the program will be operational any time soon. Attorneys Allison Fulton and Julia Kadish (SheppardMullin) write in their firm’s
Devices
FDA has classified as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due to potential incorrect display of syringe types and sizes. A recall notice says the display errors could result in delays in infusion, under-infusion, or over-infusion,
Devices
FDA has approved GE Healthcare’s shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine). The bulk package is designed to reduce the risk of breakage and injury from broken glass, the company says, adding that injuries associated with glass
Devices
FDA has published a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards. The document outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard. According to the guidance, FDA: * Will publish its justification for recognition and
Devices
FDA has released an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a “question-based approach” for its tested streamlined review which it believes will lead to a structured and consistent “ software as a medical device (SaMD)” definition in
Devices
Becton Dickinson CareFusion 303 has recalled its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or missing battery screws and broken upper and lower hinge posts and membrane frame. A damaged inter-unit interface connector may lead to interruption of communication or power between the PC
Devices
FDA has cleared an Avinger 510(k) for its TigerEye image-guided chronic total occlusion (CTO) crossing system. The device provides real-time imaging from inside the vessel during a CTO-crossing procedure, the company says. It is designed with an upgraded image capture that provides high definition, real-time
Biologics
As part of FDA’s ongoing effort to reaffirm its independence and integrity in the face of Covid-19 political pressures, the eight career agency executives who oversee the work of the Centers have signed a statement saying they are “following the science to protect public health” in the pandemic.
Devices
FDA has cleared a Minnetronix Medical 510(k) for the MindsEye Expandable Port for neurosurgical procedures. The expandable port is designed for use in treating stroke, cancer, and other conditions. “The device’s dynamic retraction creates a custom-sized channel allowing surgeons to reach target areas deep within the brain,
Devices
An 8/27 CDRH Webinar explored for developers and manufacturers of neurological and physical medicine devices the potential use of the de novo pathway to market new medical devices for which there is no legally marketed predicate device. CDRH Office of Neurological and Physical Medicine Devices director Carlos Pena said
Devices
FDA has updated its Frequently Asked Questions (FAQs) document that explains how a manufacturer distributing medical devices under an emergency use authorization or following a Covid-19 enforcement policy guidance that has not completed registration and listing can sign up for an electronic Medical Device Reporting account and submit medical
Devices
Writing in an online opinion column at The Hill, CDRH director Jeffrey Shuren and Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel say the Center has authorized over 200 Covid-19 tests in just over 200 days since the first diagnostic test was authorized. “The sheer volume