Devices
As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA has announced a new policy to permit certain laboratories to use tests they develop and validate to improve the testing capacity in the U.S. Earlier test kits developed by
Devices
FDA has released a final guidance on “Bone Anchors — Premarket Notification (510(k))Submissions.” The document provides submission recommendations for bone anchor (suture anchor) devices, which are indicated for attaching soft tissue to bone. It clarifies and provides current thinking on performance testing recommendations and device descriptions. Additionally, it addressed
Drugs
FDA says an unidentified drug manufacturer has alerted the agency about a drug shortage related to a manufacturing site affected by the coronavirus. “The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” FDA commissioner Stephen Hahn says. “It is important to
Devices
FDA has cleared a Companion Medical 510(k) for its InPen bolus insulin calculator for fixed dosing and meal estimation. The device takes into consideration each user’s current glucose level and active insulin (the calculation of the amount of insulin still lowering glucose from previous bolus doses), the company
Devices
FDA has cleared a Baxter International 510(k) for its Peri-Strips Dry with Veritas Collagen Matrix (PSDV). The company says the device is a staple line reinforcement material that bariatric surgeons have used to mitigate staple line complications for more than 15 years. The new generation device is two
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts to clarify through draft guidance the appropriate mechanisms and pathways for combination product sponsors to obtain agency feedback, including the inclusion of best practices regarding interactions between FDA and combination product sponsors. “While PhRMA appreciates the inclusion of
Devices
The National Evaluation System for health Technology Coordinating Center (NESTcc) has published the NESTcc Data Quality Framework and NESTcc Methods Framework. The group says the frameworks were developed by subcommittees of experts from FDA, health systems, academia, and industry to provide guiding principles for medical device ecosystem stakeholders to ensure
Devices
FDA has classified as Class 1 a King Systems recall of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image, which could potentially result in difficulty navigating during intubation or delay intubation. Affected device images may appear normal, but user’s actions will
Drugs
FDA says it has received reports of “spot shortages” of some medical devices due to the global coronavirus outbreak. An FDA spokeswoman tells FDA Webview 2/27 that the agency is “currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and
Devices
FDA has posted a safety communication to alert consumers and healthcare providers to the fact that the agency has not authorized for market any products using ozone gas or ultraviolet light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories. The notice says that most often
Drugs
A New York federal judge has ruled that data from clinical trials conducted for not-yet-approved drugs and medical devices over a 10-year period between 2007 and 2017 must be published online at ClinicalTrials.gov. The ruling comes in a 2018 suit against HHS, FDA, and the National
Drugs
HHS deputy inspector general for evaluation and inspections Suzanne Murrin says the Office of Inspector General has identified risks associated with medical device safety and security and safety concerns with FDA-regulated drugs. In testimony before the House Appropriations Committee, Murrin says FDA: * needs to further mitigate the risk of
Devices
Attorneys Jeffrey Gibbs and Véronique Li (Hyman, Phelps & McNamara) say an increased tendency for CDRH to miss a variety of deadlines is a concern and starts to form “a troubling pattern.” Writing online in their firm’s FDA Law Blog, Gibbs and Li give examples of the types of
Devices
CDRH is soliciting voluntary participants for a pilot of its eSTAR (Electronic Submission Template and Resource) program. A Federal Register notice says that the eSTAR pilot is voluntary and intends to improve consistency and efficiency in both industry’s preparation and FDA’s review of 510(k) submissions. The notice
Devices
A 9/17-10/29/19 FDA inspection at Unetixs Vascular, North Kingstown, RI, found Quality System Regulation violations in the firm’s manufacturing of vascular diagnostic ultrasound systems such as its MultiLab series of devices. A 2/4 Warning Letter says significant violations were: * failing to establish and maintain
Devices
FDA says it has taken several steps to make the use of laparoscopic power morcellators safer in gynecologic surgeries. The agency approved updated labeling for the PneumoLiner containment system that contains tissue to be morcellated during gynecologic surgery, issued a safety communication, and approved a new draft guidance. The updated
Devices
FDA has cleared an Emagine Solutions Technology 510(k) for its VistaScan mobile ultrasound. The device is intended to transform a clinician’s cell phone or tablet into a portable ultrasound. The system comprises compatible FDA-cleared ultrasound probes that interface with the company’s VistaScan software application. The software’
Devices
FDA says it cleared 2/25 a new version of the LivaNova heater-cooler system 3T that has changes to help reduce the risk of patient infections, including updated labeling with validated cleaning and disinfection instruction and the 3T aerosol collection set. Announcement of the clearance was included in an
Devices
Tytek Medical has recalled its PneumoDart-Pneumothorax Needle due to the risk of blocked needles, which is caused by the presence of adhesive from the assembly process. “If the needle is blocked, emergency treatment is delayed which can lead to heart or lung failure, or death,” a recall notice says.
Devices
FDA has issued two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments (CLIA) waivers for certain products. The first guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, is intended to assist manufacturers in using the agency’s dual 510(k) and CLIA
Devices
FDA has granted de novo marketing authorization to Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit for detecting a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing
Devices
FDA has cleared an Avanos Medical 510(k) for its new, 80-Watt Coolief Radiofrequency (RF) system for pain-reducing neurological lesion procedures. The device includes an RF generator, peristaltic pump and therapy cables that allows physicians to perform cooled, standard, pulsed, transdiscal and dual bipolar RF procedures, the company