Devices
CDRH chief medical officer William Maisel has reaffirmed the agency’s intention to modernize its Quality System regulation (QSR) for medical devices by harmonizing and “supplanting” existing requirements with the specifications in ISO 13485:2016. The agency noted its desire to harmonize the QSR in a Unified Agenda notice earlier
Devices
FDA has cleared a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System. The device is made using the company’s proprietary 3D-printed titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone, the company
Devices
FDA has cleared an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that the company says features a “modern anatomic nail curvature in a universal nail that can be surgically implanted from antegrade or retrograde orientations with a dedicated instrumentation kit.” It offers several versatile
Devices
FDA has cleared a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass that is, according to the company, dimensionally integrated within a collagen and sodium hyaluronate scaffold. The device’s porosity was specifically designed for optimized absorption of bone
Devices
FDA has issued a final guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics” that is intended to promote consistency, predictability, and transparency in the device submission review process when determining substantial equivalence for devices that have different technological
Devices
Getinge has begun a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps (IABP) sold by Datascope Corp. due to a potential interruption or inability to start therapy. The issue involves certain intra-aortic balloons prior to or during the use with Cardiosave IABP for users
Devices
FDA is disputing findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions, such as rheumatoid arthritis and scleroderma, in patients with breast implants. “We respectfully disagree with the authors’ conclusions,” an agency notice says. “In our editorial response, we note our concerns
Biologics
FDA has issued a draft guidance describing its current thinking on civil money penalties relating to requirements to submit registration and/or results information to ClinicalTrials.gov and/or certain certifications to FDA. The draft addresses these questions: * how CBER, CDER, and CDRH intend to identify whether responsible parties have
Drugs
The Clinical Trials Transformation Initiative has released a one-page summary of a 6/2018 expert meeting it convened to discuss best practices and needed resources for advancing use of real-world evidence in randomized clinical trials. The meeting included investigators, patients, regulators, technology experts, sponsor representatives, and other groups,
Devices
FDA has published a guidance, Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing, to address safety concerns about serious and fatal events related to use of heparin sodium products. The document notes that the U.S. Pharmacopeia (USP) drug substance monograph for heparin sodium and
Devices
[Analysis by Jim Dickinson] After a decade of stonewalling injured patients’ complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH last week lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a 9/18 statement that doubled
Devices
AdvaMed says that to develop appropriate solutions to pediatric device development, it is important to understand existing barriers. Responding to an FDA public meeting on pediatric medical device development, the association provides a series of recommended solutions that are intended to reduce risk in pediatric device development by (1) reducing
Devices
FDA has cleared an Olympus 510(k) for its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The product line has designed to be used with
Devices
A 6/1-6/6 FDA inspection at ITG-Medev, San Francisco, CA, found Quality System regulation violations in the firm’s manufacturing of Omiderm, a wound dressing product. A 9/7 Warning Letter says that specific violations were: * failing to ensure processes whose results cannot be fully verified by
Devices
FDA has cleared a Meditech Spine 510(k) for its Cure Opel-C Plate System, an add-on technology to its already cleared Cure ACP System and Talos-C (HA) Interbody Systems. With the clearance, Meditech says it will now offer two additional plating options with its Talos line of
Devices
Attorney Bradley Thompson (Epstein Becker Green) says some medical device industry people are concerned about the FDA 9/11 clearance of two Apple products that came one day before a company launch event for the products. Writing in an online post, Thompson says that while the agency’s goal for
Devices
FDA has approved a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. This is the first device approved by the agency for this indication in 17 years, a
Devices
FDA has issued a safety alert on Alcon’s CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye damage. The device is used to drain fluid that causes high eye pressure and vision loss in people with
Devices
FDA says it is issuing a comprehensive plan to streamline agency review of medical device premarket submissions that have already undergone a review by qualified expert third parties. The plan sets a goal of having at least 85% of Third Party (3P) Review Program submissions proceed without substantive FDA re-
Devices
FDA commissioner Scott Gottlieb says the agency is working on a new framework for appropriate regulation of diagnostics so that doctors and patients can get more of the information they need to pursue the right treatment at the right time and for the right patient. In a 9/13 speech
Devices
FDA has issued a draft guidance, Recognition and Withdrawal of Voluntary Consensus Standards, and a final guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, and will hold a 10/25 Webinar on the final guidance. The draft document was developed to provide guidance about the
Devices
Attorneys Suzan Onel and Jacqueline Chan (Kleinfeld, Kaplan and Becker) say that 2018 has brought a “flood of guidance documents FDA has issued related to medical devices.” In an alert, the attorneys highlight some of the most notable guidance documents issued between 1/1 and 8/30 as they relate