Devices
The average time for FDA to review and make a decision on 510(k)s dropped to 122 days in FY 2015, which is five days faster than 2014, and 23 days (16%) faster than in 2012 when it took 145 days, according to just-released medical device user fee
Devices
FDA has approved Roche’s cobas EGFR Mutation Test v2, a companion diagnostic for the cancer drug Tarceva (erlotinib) that is the first blood-based genetic test detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients, according to an agency release. “With the cobas
Devices
Three CDRH officials say the Expedited Access Program (EAP), which is completing its first year, allows FDA and medical device sponsors to focus on the early stages of product development, which can be helpful for new products that address unmet and critical life-threatening patient needs. “In fact,” they write
Drugs
Republican leaders of the House Energy and Commerce Committee say they understand that FDA’s failure to publicly clarify its thinking on communication of truthful and non-misleading information on off-label uses of drugs and medical devices may be due to a disagreement between FDA and HHS leadership. In
Drugs
The U.S. Chamber Institute for Legal Reform says that although it is too soon to measure the full impact of the 9/2015 Justice Department policy memorandum directing attorneys to focus enforcement efforts on holding individuals accountable for corporate malfeasance (memo from deputy attorney general Sally Yates), “it is
Devices
A petition submitted to FDA by Philadelphia heart surgeon and power morcellation activist Hooman Noorchashm asks that the agency revoke CDRH clearance of the Advanced Surgical Concepts Pneumoliner containment system use with power morcellators. The petition says that the clearance should be revoked “on the basis of inadequate oncological safety
Devices
FDA has issued a draft guidance, FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions, modifying the agency’s current policy on the subject. The document is intended to implement a 12/2/15 memorandum of understanding between
Devices
The FDA Circulatory Devices Panel of the Medical Devices Advisory Committee will discuss at its 6/2-3 meeting concerns about the adequacy of cleaning and disinfection of heater-cooler devices (HCD) and how to best remediate the mode of nontuberculous mycobacteria (NTM) aerosolized transmission from the heater-cooler device
Devices
FDA has classified as Class 1 a Medtronic recall involving its battery pack used with the Capnostream 20 and Capnostream 20p Patient Monitors due to the potential for thermal runaway that presents a fire risk to the monitor. The pack powers the monitor when AC power is not available or
Devices
FDA officials and industry representatives discussed a comprehensive MDUFA 4 reauthorization package offered by AdvaMed, MDMA, and MITA at their 4/27 reauthorization meeting. Meeting minutes say that the package included potential commitments and proposed resource estimates for several areas, including pre-submissions, quality management, total product life cycle, de
Devices
Halloran Consulting Group principal consultant Michael Wienholt says that the fact that a medical device firm has received ISO 13485 certification does not mean that it is complying with FDA Quality System regulations. “The basic message is that conformity to a standard does not equal compliance with a regulation,” Wienholt
Devices
FDA has approved a Roche PMA for its cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients for monitoring CMV treatment. The company says the test was the first in vitro diagnostic test conforming to a WHO International Standard, making it possible for laboratories worldwide to obtain comparable
Devices
A 1/19-2/5 FDA inspection at the Germantown, MD, manufacturing facility operated by Germany’s Qiagen found multiple violations in the firm’s manufacturing of the QuantiFERON-TB Gold test device, according to a 5/16 Warning Letter. Violations listed on an FDA-483 included: * procedures for corrective
Devices
Alcon has recalled its Ophthalmic Valved Trocar Cannula (23G and 25G) because the devices have the potential to leak beyond their design specification. They provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy surgeries, according to an
Devices
FDA has cleared a Perimeter Medical Imaging 510(k) for its OTIS 1.0 Optical Coherence Tomography System. The company says the device provides “high-resolution, real-time imaging of the periphery of excised tissue, enabling clinicians to visualize sub-surface structures up to 2 mm below the surface. These
Devices
CDRH has posted a learning module on early feasibility studies to help sponsors develop an IDE plan. Such early studies are designed for about 15 subjects, according to the Center, using a device design that is early in development. The studies generally provide initial clinical insights when additional nonclinical studies
Devices
The latest medical device user fee proposal from FDA would cost $329 million more than the current user fee program, according to just-released user fee negotiation meeting minutes. FDA said the proposal addresses key innovation initiatives that are important to patient and consumer groups, such as patient input, real
Devices
FDA has cleared an EndoChoice Holdings 510(k) for the Orca sterile, single-use air/water and suction valves for Olympus 160, 180 and 190 Series flexible endoscopes. The company says the device is designed to eliminate the need to clean and disinfect reusable valves. It adheres to recently published
Devices
FDA should require more rigorous clinical studies for high-risk medical devices used in obstetrics and gynecology than currently required, according to researchers from Northwestern University. Their study, published in the journal Obstetrics and Gynecology, found that some high-risk devices were approved based on flawed data. “We found that
Devices
FDA has granted Profound Medical Investigational Device Exemption approval to begin a pivotal clinical trial to evaluate the efficacy of the TULSA-PRO System in patients with localized prostate cancer. The device is designed to combine real-time Magnetic Resonance Imaging with “transurethral robotically-driven ultrasound and closed-loop thermal
Devices
B. Braun Medical has agreed to pay the U.S. government $7.8 million to resolve its criminal liability for selling contaminated pre-filled saline flush syringes in 2007. The syringes had a B. Braun label but were manufactured by another company, according to a Justice Department (DoJ) release. The
Drugs
The 2016 first quarter Stericycle Recall Index says that the number of recalled drug and medical device units dropped significantly in the quarter. The analysis shows that while the number of drug recalls remained consistent with the historical average, the number of units affected dropped to the second lowest quarter