Drugs
FDA says healthcare providers and patients should be aware that claims for many genetic tests to predict a patient’s response to specific medications have not been reviewed by the agency and may not have the scientific or clinical evidence to support such use for most medications. An agency safety
Devices
FDA has permitted the de novo marketing of 23andMe’s Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The
Devices
The HHS Inspector General (OIG) says FDA should take steps to have its policies and procedures better address medical device postmarket cybersecurity risks. In a report, OIG says it conducted an audit because it had identified ensuring the safety and effectiveness of medical devices and fostering a culture of cybersecurity
Devices
FDA says it is evaluating recent reports of Getinge’s Maquet/Datascope intra-aortic balloon pump devices shutting down while running on battery power. A letter to healthcare providers says the devices are used on critically-ill patients in healthcare facilities, including during transport. “An interruption in treatment can result
Devices
FDA has cleared an OsteoRemedies 510(k) for the Remedy Spectrum GV Hip Spacer System and Spectrum GV Bone Cement, which are intended to provide surgeons with a broad-spectrum treatment option with both gentamicin and vancomycin. The device is indicated for temporary use (maximum 180 days) as an adjunct
Devices
CDRH director Jeffrey Shuren says FDA is “confident that the current safety limits for cell phone radiofrequency energy exposure remain acceptable for protecting the public health.” Shuren issued a statement to comment on findings from research conducted by the National Toxicology Program that found “clear evidence” of carcinogenic activity in
Devices
Saying they are not currently considered viable candidates for final action, FDA is withdrawing two proposed medical device rules. An 11/1 Federal Register notice says that as part of its regulatory reform process, the agency reviews the backlog of proposed regulations that have not been finalized. The two proposed
Devices
FDA has cleared an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrument. The new molecular test is intended to detect and differentiate herpes simplex viruses 1 and 2 nucleic acid isolated from swab specimens from
Devices
FDA has cleared a Stimwave Technologies 510(k) for the WaveCrest Mobile iOS Platform patient controllers for opioid-free pain management. This clearance gives patients iPhone and Apple Watch mobile control over the company’s multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) System for chronic
Devices
University of Toledo Colleges of Engineering and Medicine professor Aakash Agarwal says FDA should stop clearing 510(k)s and approving PMAs for reprocessing of pedicle screws and other implantable orthopedic devices, and should stop clearing 510(k)s for reusable implantable orthopedic devices. A 10/31 petition describes in
Devices
FDA has posted details of an “Accreditation Scheme for Conformity Assessment (ASCA)” pilot program that “aims to enhance the predictability of the medical device review process by reducing premarket questions in areas where current conformity activities result in inconsistent testing practices, conformance declarations, and regulatory review.” ASCA seeks to increase
Devices
A 3/19-3/22 FDA inspection at Leventon S.A.U., Barcelona, Spain, found Quality System Regulation violations in the firm’s manufacturing of the Dosi Flow elastomeric infusion pump and Dosi Flow administrative set. A 9/5 Warning Letter says that specific violations listed on an FDA-483
Devices
FDA has cleared an Align Technology 510(k) for the Invisalign treatment with mandibular advancement, a clear aligner solution for Class 2 teeth alignment correction in tween and teen patients. The device is designed to move the lower jaw forward while simultaneously aligning the teeth. It is intended to replicate
Drugs
New research published in the 10/25 online PLOS One journal and supported by CDRH’s Division of Biostatistics outlines an approach that could lead to more patient-reported outcome measures (PROM) being included in drug and device labeling. The researchers say the “PROM has to be valid, reliable and
Devices
CDRH has posted information on its Accreditation Scheme for Conformity Assessment (ASCA), an expansion of the Center’s standards program to include a pilot accreditation initiative to improve the device review process. The post says ASCA allows FDA to work directly with accreditation bodies that will accredit testing laboratories to
Devices
FDA has issued a revised 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
Devices
FDA has issued a white paper and will hold a 12/10-11 public workshop to gather feedback and comments on the distinction between servicing and remanufacturing of medical devices. The white paper is intended to guide discussion at the workshop through the agency’s initial thoughts about guiding principles,
Devices
FDA has cleared a Rocky Mountain Orthodontics 510(k) for Orthocaps, a transparent and removable appliance for correcting tooth malpositions. Orthocaps features two different “aligners” for both day and night use, according to the company. The devices are manufactured by Ortho Caps GmbH (Hamm, Germany). During each treatment phase, patients
Devices
A new safety alert warns against an increased risk of corneal haze associated with Optics Medical’s Raindrop Near Vision Inlay. The inlay is a transparent, curved hydrogel disc smaller than the eye of a needle. It was designed to be surgically implanted into the cornea to improve near vision
Devices
FDA has announced a voluntary Optical Coherence Tomography (OCT) Premarket Notification (510(k)) Pilot Program, which is intended to develop and refine individual premarket testing recommendations for OCT devices through the pre-submission process to yield more consistent premarket submissions and improve review process predictability. “We are planning to achieve
Devices
FDA has cleared a Levita Magnetics 510(k) for an expanded indication to market the company’s Levita Magnetic Surgical System for use in bariatric procedures. Previously, the device was indicated for use in gallbladder removal procedures. It is designed to grasp and retract the body and the fundus of
Devices
FDA has updated a safety communication to reduce potential cardiac surgery infection risks associated with the LivaNova 3T Heater-Cooler Systems. The update follows a 10/18 medical device correction letter from LivaNova to inform customers of actions to take to reduce potential infections. The device is intended to provide