Devices
FDA has posted a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. Under Section 506J, FDA requires notification of a permanent discontinuance or interruption in the manufacturing of a device that is likely
Devices
Cardiovascular Systems has initiated a Class 1 recall of its Wirion system due to complaints about filter breakage during retrieval. The device is used to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures. “Under certain circumstances, such as when the
Devices
FDA has cleared a Becton, Dickinson (BD) 510(k) for the BD Kiestra IdentifA system, which is designed to automate preparation of microbiology bacterial identification testing. The device allows lab technicians to use BD Synapsys informatics to select discrete bacterial colonies from a digital plate image, according to the company.
Devices
FDA has cleared a Biolase 510(k) for the EdgePro system for cleaning and disinfection during root canal procedures performed by endodontists. The laser-assisted microfluidic irrigation device uses the company’s Er,Cr:YSGG 2780 nm wavelength laser technology, which was shown to provide debridement, cleaning, and disinfection by
Devices
Medtronic has recalled its Synergy Cranial and StealthStation S7 Cranial software due to potential inaccuracies caused by the device’s Biopsy Depth Gauge Cycle View. “If the user encounters the software issue where the graphical Biopsy Depth Gauge is no longer synchronized with other navigation views, it may result in
Devices
A federal grand jury returned 1/5 a superseding indictment charging North Carolina physician Anita Jackson with adulteration of medical devices, paying illegal remunerations, making and using materially false healthcare documents, mail fraud, and conspiracy. She faces a maximum of 20 years in prison and $250,000 in fines. The
Devices
FDA has given 510(k) clearance to the VySpine VySpan posterior cervical thoracic system. The company says the system features various screw and hook options, multiple transition rods, and crosslink versatility.
Devices
FDA has cleared a Meridian Bioscience 510(k) for the Curian Campy assay, a rapid, qualitative fluorescent immunoassay for detecting Campylobacter-specific antigen including C. jejuni, C. coli, C. upsaliensis, and C. lari in human fecal specimens. It produces objective results in about 20 minutes on the company’s Curian
Devices
FDA has cleared a Helios Cardio 510(k) for CardiaMend Pericardial and Epicardial Reconstruction Matrix, an acellular collagen matrix derived from fetal bovine dermis that is indicated for both pericardial repair and reconstruction, and epicardial support and repair. The device is supplied in a variety of sizes and two thickness
Devices
Attorney Bradley Thompson (Epstein, Becker & Green) says the county in which a medical device manufacturing facility is located “has a big impact on the likelihood of inspection” by FDA. Writing in the National Law Review, Thompson says his analysis did not show a relationship between FDA district offices or
Devices
Attorneys Jeffrey Gibbs and Gail Javitt say FDA policies and decisions have contributed to the current shortage of Covid diagnostic tests and the agency needs to look at its policies and actions and make changes before the next pandemic comes. Writing in their firm’s FDA Law Blog, Gibbs and
Devices
The Cybersecurity and Infrastructure Security Agency published a 12/21/21 vulnerability medical advisory on the Fresenius Kabi Agilia Connect Infusion System. An FDA notice cautions that successful exploitation of the system’s vulnerabilities could allow an attacker to gain access to sensitive information, modify settings, or perform arbitrary actions
Devices
In an update on Center activities and resources, CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say they will work in 2022 toward a gradual transition to normal review timelines from the changes that were made to accommodate staff needs for Covid-19 activities.
Devices
A 7/19-8/5/21 FDA inspection at DSAART, doing business as Alpha Aesthetics, Carson City, NV, found violations of Quality System and Medical Device Reporting regulations in the firm’s manufacturing of silicone facial and body contouring implants. A recently-released 11/24/21 Warning Letter says the
Biologics
FDA has published a draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other interested parties on the use of digital health technologies for remote data acquisition from participants in clinical investigations evaluating medical products. The document defines a digital health
Devices
A 7/15-7/30 FDA inspection at Global Medical Production, Jiaxing, China, determined that its sterile and non-sterile electrosurgical scissors, sterile electrosurgical graspers, and sterile veress pneumoperitoneum needles are adulterated due to Quality System Regulation violations. A recently-released 11/16 Warning Letter says specific violations were: * failing
Devices
FDA has published a draft guidance, Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology, highlighting technical considerations for the development of medical devices employing physiologic closed-loop control technology to ensure safe and effective use. The document also provides recommendations for the content of premarket submissions — 510(
Devices
A 6/7/21-7/7/21 FDA inspection at the Medtronic facility in Northridge, CA, found Quality System Regulation and Medical Device Reporting violations in the firm’s work manufacturing the MiniMed 600 series insulin infusion pumps and software and remote controllers used with the Paradigm and MiniMed series
Devices
FDA has published a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, to provide a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The document defines credibility
Devices
FDA has given 510(k) clearance to the Bioventus neXus bone scalpel access handpiece. The company says the device is a handheld tool designed for resection, shaving, and removal of soft tissue and bone during minimally invasive surgery. Bioventus says it will launch the neXus scalpel this year.
Devices
FDA has published a guidance, Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH), to identify the key features of non-clinical and clinical investigation plans used to support IDE applications, PMAs, de novo classification requests, and some 510(k) submissions for devices
Devices
FDA has issued a guidance, Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use—Premarket Notification (510(k)) Submissions, with submission recommendations for these devices designed to deliver irrigation fluid to a surgical site such as the knee, shoulder, hip, elbow, ankle, and wrist joints during arthroscopic procedures. The document