Devices
FDA has cleared a Luminex 510(k) for the Aries Flu A/B & RSV Assay. The test delivers results in less than two hours for detecting and differentiating three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus. The company says the assay also allows
Devices
Beginning next month (9/13), CDRH will allow the use of stand-alone symbols without adjacent text on domestic device labeling, making it consistent with symbols used on devices manufactured for European and other foreign markets. The Center conducted a 7/25 webinar to discuss its final rule on the
Devices
Boston Scientific has recalled several lots of its Lotus Valve System due to breaks in the delivery system’s release mechanism, which have resulted in three deaths from catastrophic vessel trauma. “This action is related to potential breakage of the release mandrel on Lotus Valve Systems which were manufactured prior
Devices
Bayer has won a court victory in a product liability case involving its besieged Essure contraceptive device. On 7/26, the federal court in Connecticut ruled on Norman vs Bayer, granting Bayer’s motion to dismiss because the claims were preempted by federal law or failed to provide facts to
Devices
A 3/7-3/18 FDA inspection at TriMed, Inc., Santa Clarita, CA, found Quality System Regulation violations in the firm’s manufacturing of implantable bone fixation systems and the instruments and drills used to implant the products, according to a just-released Warning Letter from FDA’s Los Angeles
Devices
FDA has issued a draft guidance, Medical X-Ray Imaging Devices Conformance with IEC Standards, to harmonize performance standards under the Federal Food, Drug, and Cosmetic Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help ensure streamlined regulatory review for submissions for medical x-ray imaging equipment. The
Devices
FDA has approved a W.L. Gore & Associates PMA for the Gore Tigris Vascular Stent, a dual-component stent with a fluoropolymer/nitinol design. The device was designed to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease, the company says. “The stent
Drugs
FDA and the HHS Office for Human Research Protections have issued a joint guidance to assist institutional review board (IRB) administrators, chairs, and other officials responsible for preparing and maintaining written procedures for the IRB. The guidance provides an IRB written procedures checklist incorporating the HHS and FDA regulatory requirements
Devices
A 5/2016 FDA draft guidance on technical considerations for additive manufactured (AM) devices is the agency’s first attempt to determine its regulation of the burgeoning 3D printing industry. Attorneys Suzan Onel and Jacqueline Chan (K&L Gates) write in an online blog post that FDA’s approach
Devices
FDA and the Centers for Medicare and Medicaid Services (CMS) have accepted a Foundation Medicine PMA for FoundationOne for a “parallel review” in order to expedite reviews of the oncologic comprehensive genomic profiling assay. FDA also accepted the company’s request for review as part of its Expedited Access Pathway
Devices
The Justice Department has filed suit against Jerome Hahn (Lexington, KY) and a medical device company he owns, Telehealth Holdings, for allegedly violating the False Claims Act. According to the complaint, Hahn and his company defrauded the government by submitting false claims in connection with three federal grants worth over
Devices
CDRH has posted a guidance on “FY 2017 Medical Device User Fee Small Business Qualification and Certification” that describes the process for requesting qualification and certification as a small business in order to allow reduced user fees. A small business designated company must have gross receipts or sales of no
Drugs
FDA officials say the agency will begin piloting a new inter-Center consult request (ICCR) procedure for proposed combination products. In a new agency blog post, they say that “close inter-Center collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review. A combination product
Devices
Sage Products has recalled one lot of Comfort Shield Barrier Cream Cloths due to contamination (Burkholderia cepacia) concerns. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, an FDA recall notice says. The cloths are used
Devices
CDRH has posted a Medical Device Single Audit Program document that outlines the control of quality records generated under the pilot program. The pilot is testing the feasibility of conducting a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of five
Devices
A CDRH webinar has reviewed medical device biocompatibility issues addressed in a recent a guidance on “Use of International Standard ISO 10993-1 — Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.” The Center says the document is intended to assist industry in preparing
Devices
FDA has approved a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combination with cataract surgery. The is intended to help reduce intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. The CyPass System
Devices
FDA has cleared an Itamar Medical 510(k) to expand the medical indication for its WatchPAT for sleep apnea diagnosis. The clearance covers the device’s use in patients aged 12 and older. The previous clearance was for use in those aged 17 and older. WatchPAT is a small wrist
Devices
FDA has cleared a Companion Medical 510(k) for the InPen system, its wireless-enabled insulin pen and proprietary mobile application. The device includes technology to calculate and recommend optimal dosing, track history and timing of doses, monitor insulin temperature, and track and report to the health care providers, according
Devices
FDA has issued a guidance, General Wellness: Policy for Low Risk Devices, to clarify the CDRH compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). In it, the agency says CDRH does not intend to examine these products to determine whether they are devices within
Drugs
AdvaMed says that there are significant barriers to implementing the types of systems described in an FDA draft guidance on using electronic health record (EHR) data in clinical investigations, including lack of interoperability of the systems between healthcare systems. “Some systems are not designed to communicate with other systems,” the
Devices
FDA has cleared an Instrumentation Laboratory 510(k) for the HemosIL HIT-Ab(PF4-H) assay for use on ACL TOP Hemostasis Testing Systems for detecting antibodies associated with heparin-induced thrombocytopenia. According to the company, this severe immunologic adverse reaction to a heparin complex can cause blood clots to