Devices
CDRH Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) director Alberto Gutierrez has announced he will retire at the end of September. Gutierrez joined FDA in 1992 as a CBER reviewer for vaccine adjuvants and method development for determination of the purity and structure of vaccine components. In
Devices
FDA has approved an Ortho Clinical Diagnostics BLA for the Ortho Sera blood grouping reagents designed for extended phenotype testing with the ID-Micro Typing System Gel Card technology. “During pre-transfusion testing, labs routinely encounter patient samples that require extended antigen typing for blood group system antigens beyond those
Devices
FDA says Cook Medical has initiated a correction to its “instructions for use” for the Zenith Alpha Thoracic Endovascular Graft. The correction removes the indication for blunt thoracic aortic injury or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these
Devices
CDRH has sent out a letter to medical device establishments to provide information about device user fees, including fee rates and payment procedures, for fiscal year 2018 (FY18), which begins 10/1.The letter notes that the annual establishment registration fee must be paid between 10/1 and 12/31.
Devices
FDA has told Medizone International that it should proceed to market through the de novo classification pathway for its novel AsepticSure disinfection system. The company says it intends to support its application with data demonstrating AsepticSure’s safety and efficacy profile and low-risk nature. The portable device is intended
Devices
Attorneys Jonathan Emord and Kendrick Moxon have filed a supplement to their 8/2016 petition to FDA protesting the agency’s proposed order to reclassify and make more readily available the electroconvulsive therapy (ECT) devices used in electroshock treatments. They say the reclassification would make it easier for doctors to
Devices
A CDRH report submitted to Congress shows that in FY 2016, FDA approved 68 original and panel track supplement PMA applications and three humanitarian device exemption (HDE) applications. Of the 71 total approvals, 13 PMAs and none of the HDEs were indicated for use in a pediatric population or subpopulation.
Devices
Hyman, Phelps & McNamara is asking FDA to add over-the-counter denture repair kits to the list of Class 2 medical devices with reasonable assurances of safety and effectiveness that can be exempted from 510(k) premarket notification requirements. A petition tells the agency that the kits are “low-
Devices
FDA has cleared a RevMedx 510(k) for the XSTAT 12 and XSTAT 30 hemostatic devices for controlling severe, life-threatening bleeding from narrow entrance extremity wounds. Previously limited to treating junctional wounds in the groin or shoulder area, XSTAT devices can now be used to treat severe bleeding from
Devices
The CDRH Early Feasibility Study (EFS) program offers a limited clinical investigation of a medical device early in development. It typically enrolls a small number of subjects, is used to evaluate the device design concept with respect to initial clinical safety and device functionality, and may guide device modifications, according
Devices
FDA has recognized the UL 2900-1 cybersecurity standard for medical devices, according to Emergo Group. In an online post, the company says that the standard covers general cybersecurity requirements for network-connectable devices. According to Emergo, FDA medical device applicants may declare conformity to UL 2900-1 to address
Devices
FDA’s Office of Pediatric Therapeutics has announced a 9/18-19 public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ‘Big Data’ to Pediatric Safety Studies.” The workshop’s goal is to understand how to access and analyze “big data” associated with safety information in the
Drugs
AdvaMed says the current 2003 FDA guidance on using electronic records and signatures in medical product clinical investigations is outdated and uses enforcement discretion. In its comment on a new draft guidance, the trade association says it supports the risk-based approach to validation and audit trails outlined in the
Drugs
President Trump has signed the FDA Reauthorization Act of 2017 that renews the agency’s user fee programs for another five years. Enacting the measure into law removes the threat of having to send reduction-in-force (RIF) notices to staff who are funded by user fees. In late July,
Devices
FDA says it continues to “aggressively investigate” Magellan Diagnostics LeadCare and LeadCare II blood lead testing systems due to concerns they may underestimate blood lead levels and give inaccurate results when processing venous blood samples (see earlier story). In June, Magellan recalled all lots of the tests manufactured between 9/
Devices
FDA has cleared a Globus Medical 510(k) for the Excelsius GPS, a robotic guidance and navigation system for orthopedic (screw placement applications in spine and orthopedic surgery) and neurosurgical procedures. The device integrates Globus Medical implants and instruments and is compatible with pre-operative computed tomography (CT), intra-operative
Devices
FDA says it is making available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. The panel consists of plasma samples from anonymous individuals infected with Zika, West Nile, or dengue viruses. An agency news statement says that
Drugs
A survey of 83 clinical studies supporting 78 PMA panel-track supplements approved by FDA between 4/19/06 and 10/9/15 found that only 45% were randomized clinical trials and 30% were blinded. Researchers writing in the Journal of the American Medical Association say that of the 150
Devices
Writers of a Health Affairs blog post say FDA’s new approach to digital health — shifting from premarket to postmarket review by FDA and shifting from FDA oversight to oversight by independent, non-government certifiers — raises as many questions as it answers. The post says that the 21st Century Cures
Devices
FDA has cleared a Stryker 510(k) for the Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System. The device features serrated cutting flutes, a dual-thread pattern with an increased number of leads for rapid insertion, and
Devices
Cook Medical has recalled its Zenith Alpha Thoracic Endovascular Graft when used for treating blunt traumatic aortic injury (BTAI) because blood clots may form inside the device after implantation. “Cook Medical is also aware of reported cases where the graft became blocked or closed (occlusion) when used to treat BTAI,
Drugs
Former FDA commissioner Robert Califf says a sweeping overhaul of the current clinical trial system is needed and underway. Writing in the Journal of the American Medical Association, Califf acknowledges complaints that the current system moves too slowly to approve new drugs or rushes new drugs to market without adequate