Devices
FDA has published a guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission such as
Devices
FDA has released a final guidance on “Unique Device Identification: Convenience Kits.” The document discusses an agency exception for complying with unique device identification (UDI) system regulations that require that the label and device package of a device must bear a UDI. The exception is provided for devices packaged within
Devices
Two former Arriva Medical executives will each pay $500,000 to settle False Claims Act charges that they caused the company to submit false claims to Medicare that were tainted by kickbacks paid to beneficiaries in the form of free or no-cost home blood glucose meters or waived or
Devices
FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-eluting Balloon (SEB) for treating coronary in-stent restenosis (ISR). “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential
Devices
AdvaMed says that while it appreciates FDA publication of a draft guidance on non-binding feedback after certain FDA medical device establishment inspections, the draft does not satisfactorily deliver the result that is sought — using agency feedback on remediation of inspectional observations to assure that the remediation effectively and efficiently
Devices
FDA has approved B. Braun Medical’s heparin sodium injection, USP. The company describes it as the first heparin 5,000 USP Unit/0.5 mL prefilled syringe with attached safety needle for subcutaneous and intravenous use in the U.S. It is preservative-free, not made with natural rubber
FDA Policy/General
FDA has issued a draft guidance, Initiation of Voluntary Recalls Under 21 CFR part 7, Subpart C, on the timely initiation of voluntary recalls of FDA-regulated products. The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures;
Devices
FDA has cleared a Konica Minolta Healthcare Americas 510(k) for its Dynamic Digital Radiography (DDR). The device produces medical images that depict movement and can be annotated, including diagrams, to help radiologists provide a more detailed clinical finding, the company says. “DDR, an enhanced X-ray technology, enables clinicians
Devices
FDA has issued a proposed order reclassifying certain surgical staplers and a draft guidance to help manufacturers ensure their surgical stapler and staples labeling provides adequate directions for use. CDRH director Jeffrey Shuren says the agency alerted the public and healthcare professionals 3/2019 about concerns with surgical staplers for
Devices
A 4/9-4/25/18 FDA inspection of Abaxis, Inc., Union City, CA, found violations in the firm’s manufacturing and distribution of Class 1 and Class 2 in-vitro diagnostic reagents including the Piccolo Xpress chemistry analyzer and associated rotor panels/assays. A 4/12 Warning Letter says
Devices
FDA has cleared an AliveCor 510(k) for its KardiaMobile consumer electrocardiogram (ECG) technology for expanded use to detect and show ECG results for bradycardia and tachycardia. Previously, the device was cleared to detect atrial fibrillation (AFib) and normal sinus rhythm. AliveCor says the new instant analyses indicate arrhythmias that
Devices
FDA has granted a de novo clearance to NeuroSigma for its prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System, the first medical device to treat attention deficit hyperactivity disorder (ADHD). The device is indicated for patients aged seven to12 years old who are not currently taking prescription ADHD medications.
Devices
FDA has cleared a Medicrea Group 510(k) for expanded use of its proprietary surgical planning software, UNiD Hub, to integrate a complete database of the company’s implant portfolio to directly simulate and select implants during planning for surgery. “The integration of an implant database with Medicrea’s UNiD
Devices
FDA has published a draft guidance, Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions, that, when finalized, will provide detailed recommendations for manufacturers on the information that should be included in PMA, HDE, and 510(k) submissions, IDE applications, and de novo requests for medical devices that include
Devices
FDA has published a draft guidance, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, to give the agency’s current thinking on technical considerations specific to devices using nitinol, a commonly used material in the medical device industry. The document says that medical device manufacturers have used
Devices
FDA has cleared a RMS Medical Products 510(k) for its High-Flo Super26 Subcutaneous Needle Sets, indicated for subcutaneous infusion of medications in home, hospital, or ambulatory settings to facilitate high flow rates, including human plasma-derived immunoglobulins. The product will be offered as a single-needle set, as
Devices
FDA has granted Advanced Prenatal Therapeutics a breakthrough device designation for its Targeted Apheresis Column for Preeclampsia (TAC-PE). The device is being designed to remove disease-causing factors from a mother’s blood. The company says it is intended to treat preeclampsia, a leading cause of prematurity and maternal/
Devices
Cognition, a medical device consulting firm, says FDA efforts to harmonize elements of its Quality System regulations with ISO 13485:2016, the International Organization for Standardization’s updated medical device quality management standard, “reflect actions to empower domestic manufacturers in the global marketplace.” In a white paper, Cognition says the
Devices
FDA has ordered manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to immediately stop selling and distributing the products in the U.S. An agency statement says it has determined that the products’ manufacturers—Boston Scientific and Coloplast—have not demonstrated
Devices
FDA has cleared a SI-Bone 510(k) for use of its iFuse Bedrock technology in fusion of the sacroiliac (SI) joint during long construct procedures. The company says that iFuse Bedrock is a technology designed to provide greater joint stabilization at the base of long spinal constructs. The device
Devices
Brainlab has recalled its Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery that may prevent the surgeon from accurately navigating surgical tools inside the patient. Incorrect information during surgery could result in damage to a patient’s body, or a second,
Devices
FDA has approved an Intact Vascular PMA for the Tack Endovascular System, a dissection repair device implanted post-angioplasty in patients with peripheral arterial disease. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated safety and effectiveness. The trial