Devices
FDA has approved a Roche PMA for its CINtec Plus Cytology as a biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas 4800 HPV Test. The test identifies those women whose HPV infections are most likely to
Devices
A 3/2 CDRH Webinar explained the FDA guidance on policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to emergency use authorization (EUA) for coronavirus disease during the public health emergency. On the program, Office of Product Evaluation and Quality director of the
Devices
HeartWare has recalled (Class 1) its Ventricular Assist Device (HVAD) system battery charger due to the potential for the charger to be mistakenly inserted into the device’s controller power port. The HVAD is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a
Devices
Former FDA commissioner Scott Gottlieb says he had been calling for a fuller federal government response to the coronavirus public health emergency for the last six weeks. In a 3/9 session with the USA Today editorial board, Gottlieb said: “The mistake we made is we took a very linear
Devices
FDA has issued a final guidance on “Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.” The agency says that electrosurgical devices used in general surgery are designed to cut and remove tissue and control bleeding through the use of high-frequency electrical current. The electrosurgical devices may
Devices
FDA has classified as Class 1 a Becton Dickinson/CareFusion recall of 774,000 Alaris System infusion pumps and modules due to software and system errors. According to a recall notice, the devices have experienced low battery alarm failures, “Keep vein open/End of Infusion” alarm priority errors, custom concentration
Devices
The Justice Department has filed two False Claims Act lawsuits against SpineFrontier and related entities and executives, alleging that the company paid kickbacks to spine surgeons to induce the use of SpineFrontier surgical devices, which is in violation of the Anti-Kickback Statute. According to the complaint, defendants paid spine
Devices
U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) have introduced the bipartisan Verifying Accurate, Leading-edge IVCT Development Act that is intended to increase diagnostic testing capabilities to better respond to emerging public health threats, like the coronavirus. The bill would codify FDA’s recent temporary
Drugs
Stericycle’s first annual State of the Nation 2020: Product Recall report projects increased regulation by FDA and other government agencies this year. The report combines a look at recall activity in 2019 with projections for the future. The 2019 recall story for drugs, Stericycle says, centered on supply chain
Devices
Bipartisan legislation has been introduced in the House and Senate to increase the diagnostic capabilities of health laboratories across the U.S., in part to better respond to emerging public health threats such as the novel coronavirus. The bill follows complaints from public health officials that a current FDA policy
Devices
FDA has announced a 4/7 public meeting on reauthorizing the Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current device user fee program expires on 10/1/2022, and new legislation will need to be enacted beforehand to allow user fee collection and
Devices
[Report by David McFarland] The Trump Administration continues to lose credibility with its handling of the coronavirus outbreak. After promising to deliver up to 1.5 million tests for coronavirus by the end of the week, vice president Mike Pence now says that goal won't be met and
Devices
FDA has published a final rule to ban electrical stimulation devices used for self-injurious or aggressive behavior. An agency media statement says the devices “present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.” The devices administer
Drugs
[Analysis by David McFarland] Missteps by federal agencies and the Trump Administration grappling with the coronavirus outbreak will no doubt make a nice “lessons learned“ case study one day on what not to do the next time the U.S. faces a pandemic. Because we at FDA Webview tend to
Devices
FDA has cleared a Biogennix 510(k) for an expanded indication for its Agilon moldable bone grafting product — use in posterolateral spine procedures when mixed with autograft. The device contains a high purity, Type 1 fibrillar bovine collagen, which is intended to provide a site for cell attachment, migration, proliferation,
Devices
FDA has posted a draft guidance on “Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for such devices if sponsors opt to use the alternative pathway to support substantial equivalence, instead of a direct comparison of a predicate device’
Drugs
Teva says it is generally pleased with an FDA draft guidance on product development and quality considerations for transdermal and topical delivery systems but believes there are some technical issues that require further clarification. The company’s comment letter raises several line-by-line technical issues for clarification. Mylan says
Devices
A 7/29-8/1/19 FDA inspection at Silfradent Srl, Santa Sofia, Italy, found violations of the Quality System regulation in the firm’s manufacturing of the Surgybone SB 300NA. A just-released Warning Letter says specific violations were: * failing to establish and maintain procedures to control the device
Devices
FDA and the Centers for Disease Control and Prevention have taken action to make more respirators available to health care personnel. Most respirators on the market today are indicated for use in industrial settings, an FDA notice says. The action grants an emergency use authorization to allow certain National Institute
Devices
FDA is informing patients, healthcare providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities that may introduce risks for certain medical devices. An agency online notice says FDA is not aware of any confirmed adverse events related to the vulnerabilities. “Software to exploit these vulnerabilities in certain situations is
Devices
FDA says a 7/18-7/30/19 inspection at CPAPNEA Medical Supply, Phoenix, AZ, determined that the company manufactures the Optipillows EPAP mask that is adulterated because the company does not have an approved PMA in effect for the device. A 1/23 Warning Letter says the device is
Devices
FDA has cleared an FX Shoulder 510(k) for its Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplasty. The device features seven different central screw size length options ranging from 8mm to 20mm in 2mm increments. The company says that the 32mm