Devices
FDA has announced a pilot program on “Approval Application Critical to Quality (PMA CtQ)” which aims to evaluate device design and manufacturing process quality information early in device development. The pilot is intended to provide qualifying PMA applicants with the option to engage FDA on developing CtQ controls and earn
Devices
FDA has cleared a Spinal Resources 510(k) for its Swedge Pedicle Screw System. The device offers cobalt-chromium and titanium tulips, double lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws, and minimally invasive spinal surgery options, according to the company. Currently, it is cleared for a
Drugs
A 2/20-3/24 FDA inspection at Pfizer’s Meridian Medical Technologies manufacturing facility in Brentwood, MO, which holds a contract to produce EpiPen and EpiPen Jr. for Mylan, found significant violations of current good manufacturing practice (CGMP) requirements for combination products, according to a 9/5 Warning Letter
Devices
FDA has cleared an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache. The prescription-only device uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain, according to the company. It says
Devices
A Minnesota federal court has dismissed a whistleblower’s fraud on FDA claims against Boston Scientific Corp., but will allow him to re-file the allegations with greater particularity. Attorney Jennifer Thomas (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the case involves two of
Devices
FDA has cleared an OmniLife Science 510(k) for its proprietary robotic tissue balancing device for use with the company’s OmniBotics robotic-assisted total knee replacement technology platform. The device is intended to provide surgeons with a quantitative tool to actively manage the soft tissue envelope with real-time
Devices
AdvaMed says it does not believe FDA should issue a final guidance based directly on an International Medical Device Regulators Forum (IMDRF) proposed document on software as a medical device. “The IMDRF document is grounded on a classification scheme that does not align with FDA’s statutory framework and, therefore,
Devices
FDA has issued a guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, highlighting considerations the agency believes should be included in the development and design of interoperable medical devices and providing recommendations for the content of premarket submissions and labeling for such devices. The document says
Devices
FDA says it has learned that QLRAD Netherlands is marketing the RectalPro Endorectal Balloon in the U.S. without marketing clearance or approval. A just-released 7/20 Warning Letter says the agency reviewed the company’s Web site and brochures it distributed at medical conferences in 2015 and 2016
Devices
FDA says that a 12/12-12/16/16 San Francisco District Office inspection at Steiner Biotechnology, Henderson, NV, found objectionable conditions in the firm’s role as sponsor-investigator in significant risk clinical studies of Ridge Graft and Skeletal Graft. According to a just-released 6/21 Warning Letter,
Devices
A 9/6-9/27/Entellus Medical, Plymouth, MN, found “objectionable activities” in the firm’s role as sponsor of a significant risk study of the XprESS Multi-Sinus Dilation System and the Path Assist Confirmation Tools conducted under an IDE, according to a just-released 4/6 Warning Letter.
Devices
An FDA safety alert warns medical professionals to not use alcohol pads or benzalkonium chloride antiseptic towelettes made by China-based Foshan Flying Medical Products Co. due to a lack of sterility assurance and other quality issues. The products are distributed by Total Resources International, Walnut, CA, and Simple Diagnostics
Devices
FDA has cleared a GE Healthcare 510(k) for the Senographe Pristina with Self-Compression, the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their breast before the mammogram x-ray is taken. The device has a handheld wireless remote
Devices
FDA has issued a finalized guidance, Procedures for Meetings of the Medical Devices Advisory Committee, with information on the processes for meetings of the various Medical Devices Advisory Committee panels, other than the dispute resolutions panel. A draft of the guidance was issued 4/1/15. It supersedes a 7/
Devices
Two CDRH Division of Cardiovascular Devices staffers say the Center’s early feasibility study (EFS) program worked well for the Bio2 Medical Angel Catheter, which was one of the studies included in the EFS pilot. Writing in the Journal of Vascular Interventional Radiology, the two say an EFS is a
Devices
Spectranetics has recalled its Bridge Occlusion Balloon due to the potential for a blocked guidewire lumen. The device is indicated for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. To date, Spectranetics has received nine customer complaints, none of which
Devices
FDA will publish 8/31 a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, to clarify how the agency evaluates real-world data to determine if they are sufficiently relevant and reliable to generate the types of real-world evidence that can be used
Devices
In a letter to healthcare professionals, FDA is reminding them that using thermoregulation devices during surgery, including forced air thermoregulating systems, have resulted in less bleeding, faster recovery times, and decreased risk of infection for patients. The agency says it recently became aware that some health care providers and patients
Devices
A CDRH webinar on the Medical Device Development Tools (MDDT) voluntary qualification program listed its benefits as (1) leveraging advances in regulatory science that help to bridge the gap between research and development of medical devices and the delivery of high quality, safe, and effective devices to patients; and (2)
Devices
FDA has cleared a Smiths Medical 510(k) for the CADD-Solis ambulatory infusion pump with wireless communication. The company says the device can communicate wirelessly with the company’s PharmGuard Server software for updates, access to drug libraries, and remote managing of pump performance and drug dosing. It also
Devices
FDA says it has approved a firmware update to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities in some Abbott (formerly St. Jude Medical) pacemakers. An agency safety communication says the update is for the Accent, Anthem, Accent MRI, Accent ST, Assurity, and Allure implantable
Devices
FDA has cleared a Leica Microsystems 510(k) for its FL560 fluorescence microscope filter for visualizing cerebrovascular blood flow in conjunction with the dye fluorescein. “When integrated into a M530 OH6 neurosurgical microscope, FL560 fluorescence provides real-time, high-contrast visualization of both cerebral anatomy in native color and fluorescent