Devices
Consumers for Dental Choice has filed a citizen petition with FDA asking that the agency take steps to warn against amalgam use in children, pregnant women, and other sensitive populations by: * issuing a safety communication warning dentists, parents, and dental consumers against amalgam use in children, pregnant women, and other
Drugs
[Report by John Hope] Congressional observers see the possibility that a lame duck session of Congress opening 11/14 will fast-track approval of the 21st Century Cures legislation that has made its way in companion bills through both the House and Senate. With Republican control of both the House
Devices
FDA has given 510(k) clearance to Syneron Medical’s Profound fractional radiofrequency microneedling device for use with the 75˚ SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types 1-3 as supported by long-term (six months) clinical data. The company says
Devices
FDA has given 510(k) clearance to Joimax’ Vaporflex and Legato electrosurgical probes with radiowave technology for open and endoscopic spine surgery. The German company says that the probes comprise a series of instruments to facilitate delivery of electrical energy from an RF generator to patient tissue for use in
Devices
FDA has released a draft guidance document on Product Labeling for Certain Ultrasonic Surgical Aspirator Devices that provides labeling recommendations to promote the safe and effective use of aspirators. Ultrasonic surgical aspirator devices (aspirators) are surgical tools commonly used for a wide range of procedures to break down, liquefy, and
Devices
House Energy and Commerce Committee members Diana DeGette (D-CO) and Susan Brooks (R-IN) have written FDA for information about how it is working to address potential cybersecurity vulnerabilities associated with medical devices. In a letter to FDA commissioner Robert Califf and CDRH director Jeffrey Shuren, DeGette and Brooks
Drugs
Yale Law School professors Jeanie Kim and Amy Kapczynski urge FDA not to back down on its opposition to off-label marketing of drugs. Writing in JAMA Internal Medicine, the two say that the current approach to off-label marketing “has protected the public and helped provide physicians with rigorous
Devices
Johnson & Johnson says it commends FDA for creating a comprehensive and thoughtful draft guidance on when a 510(k) is necessary when implementing changes to a previously cleared 510(k) device containing software. “We particularly appreciate the collaborative approach that FDA demonstrated during the development of this document,” it
Devices
An 8/23-9/1 FDA inspection at Valeant Pharmaceuticals’ Rochester, NY, facility found Quality System Regulation violations in the firm’s work as a specification developer and distributor of the Small Particle Size Aerosol Generator, a nebulizer pneumatic flow system for administering Virazole ( ribavirin) aerosol and the OraPharma ONSET
Drugs
FDA is considering industry and advertiser proposals to allow links to risk information in promotional activities on character space-limited social media platforms like Twitter. It has announced new studies being designing to address the question of whether substantive risk information on such platforms is effective in communicating risks when
Devices
FDA has cleared an EOS Imaging 510(k) to market the kneeEOS software, an online 3D planning product that uses weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for total knee arthroplasty. “The software makes an initial automatic proposal for the size
Devices
FDA has released a final guidance on “Medical Device Reporting (MDR) for Manufacturers” that is intended to help companies meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. The document covers MDR requirements to develop, maintain, and implement written procedures for identifying and evaluating all
Devices
FDA has cleared two Medicrea Group 510(k)s for its PASSXS posterior fixation and LigaPASSXS band connector components designed to address pediatric spinal deformities in small stature patients. The company says it has worked with a team of leading pediatric spinal surgeons to develop low-profile implants specially tailored
Devices
CDRH has introduced a new program on the Patient and Care-partner Connection to allow patients and their organizations to dialog with Center staff about specific disease states and medical devices used for their treatment, diagnosis, or assessment. The program addresses one of CDRH’s key strategic priorities −partnering with
Drugs
University of Arizona/New York University law school professor Christopher Robertson and Harvard Medical School professor Aaron Kesselheim are urging FDA to stand firm against court decisions on off-label promotion that could lead the agency away from its mission to approve regulated products based solely on scientific evidence. Writing
Devices
FDA has cleared a Neural Analytics 510(k) for the Lucid M1 Transcranial Doppler Ultrasound System, a portable device designed for rapid triaging and monitoring of patients with brain disorders. The device is designed to assess brain blood flow from outside the body. It is a battery operated medical grade
Devices
FDA has cleared an Arterys 510(k) for its Arterys Software and its use in clinical settings for the quantification of cardiac flow (4D flow and 2D phase contrast workflows) and cardiac function measurements. Previously, the software was cleared for its 4D Flow visualization feature. The product specifically analyzes blood
Devices
Spectranetics Corp. has submitted a PMA for the Stellarex drug-coated angioplasty balloon, for use in restoring and maintaining blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. The device, which was first launched in Europe 1/2015, uses EnduraCoat technology, a durable, uniform
Drugs
FDA has issued a guidance, Collection of Race and Ethnicity Data in Clinical Trials, with the agency’s expectations for and recommendations on using a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated products conducted in the U.S. and
Devices
FDA has cleared a Tyto Care Inc. 510(k) for its digital stethoscope, a device that will be part of the firm’s set of telehealth digital examination tools for examining the ears, throat, skin, heart, lungs, and temperature under a cloud-based platform with video conferencing. “By enabling a
FDA Policy/General
Former CDRH senior executive Jonathan Bernstein describes in a Linkedin post his four-step plan for improving FDA, and especially the Center where he worked. His recommendations are: * find the innovators within the agency, insulate them from bureaucracy, legitimize their work, and empower these teams; * reorganize reviewer assignments to align
Devices
CDRH has been asked to evaluate information that a design flaw in the Hill-Rom Total Care hospital bed reportedly used in many ICUs across the country can put patients at risk of exposure to biohazardous materials. The concern was raised by cardiac surgeon Hooman Noorchashm, whose wife is a