Devices
The HHS Office of the Inspector General (OIG) says that FDA and the Centers for Medicare and Medicaid Services (CMS) recently took an important step when they co-signed a letter supporting capturing the device identifier (DI) portion of the unique device identifier (UDI) on claim forms for implantable devices.
Devices
A Kickstarter funding campaign launched by Tute Genomics to give consumers access to their personal genetic information has been postponed after receiving an FDA letter concerning its approach to marketing genome sequencing and analysis directly to consumers. In a note on Kickstarter, Tute Genomics CEO Reid Robison says that “after
Devices
CDRH says it is working with standards organizations, federal partners, professional societies, advocacy groups, patients and other stakeholders to reduce the chance of medical device misconnections, which may occur when one type of medical device is mistakenly attached to another device that performs a different function. “Because these connectors are
Devices
Baxter International has begun a recall of all unexpired lots of 50mm 0.2 micron filters (product code H93835) due to the potential for a filter support membrane to be missing and for the potential presence of particulate matter. “These issues are associated with a component manufactured by an external
Devices
FDA and CMS’s parallel review program has fallen short and “failed to address the real obstacles manufacturers face in getting medical devices to patients,” a new study from George Mason University’s Mercatus Center finds. Launched in 2011 (see story), the pilot anticipated approving medical devices concurrently for both
Devices
FDA and other government agencies are hosting an 11/8 public workshop on “Promoting Semantic Interoperability of Laboratory Data” that is intended to discuss proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests
Devices
FDA has cleared a NuVasive 510(k) for its MAGEC system to be surgically implanted using its Reline posterior fixation system for treating patients with severe spinal deformity conditions. MAGEC comprises a single-use spinal rod that is surgically implanted to brace the spine and includes a small internal magnet
Devices
FDA has approved a label extension for Roche’s EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s Tagrisso (osimertinib), which is indicated for patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The test
FDA Policy/General
A 9th Circuit Court of Appeals decision appears to “impermissibly grant FDA authority to regulate the practice of medicine and to further muddy the regulatory morass governing off-label use of products,” according to attorneys Anne Walsh and Andrew Hull (Hyman, Phelps & McNamara). Writing in their firm’s FDA
Devices
FDA has cleared a Becton Dickinson 510(k) for the BD Vacutainer Barricor plasma blood collection tube, a “next generation” blood collection and separation technology designed, the company says, to improve sample quality and help clinicians receive test results faster. The single-use, plastic evacuated tube uses a novel mechanical
Devices
Two CDRH officials say that under a new Use of Symbols in Labeling final rule, medical device manufacturers have three options. Senior policy analyst Antoinette Hazlett and health standards program director Scott Colburn say in an FDA Voice blog post that companies can (1) choose not to use symbols, (2)
Devices
Duke University’s National Evaluation System for health Technology (NEST) planning board has outlined key priorities for its new coordinating center as it works to implement a national system for medical device evaluation. The 25-member board includes patients, clinicians, the medical device industry, payers, and regulatory experts, as well
Devices
FDA says it has updated the Expedited Access Pathway (EAP) Program Web site with two Data Development Plan examples that are a resource for sponsors. The agency released 4/2015 a guidance that introduced that new voluntary program to promote development of innovative products to address unmet medical needs for
Devices
FDA has approved Medtronic’s MiniMed 670G hybrid closed looped system, the first agency-approved device that is intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with Type 1 diabetes. “The MiniMed 670G hybrid closed looped system, often referred
Devices
FDA has approved an Abbott PMA for the FreeStyle Libre Pro system, a continuous glucose monitoring system for healthcare professionals to use with their diabetic patients. The device is intended to provide healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), “giving a
Biologics
CDRH Division of Biostatistics deputy director Gerry Gray defined adaptive trial designs in a 9/22 webinar as “clinical studies that include some prospectively planned opportunity or set of opportunities to change the study design based on data accumulated during the course of the study without undermining the integrity and
Devices
An Ohio federal court has dismissed five cases brought against Medtronic alleging state-law liability over off-label use of its Infuse product used to stimulate bone growth in spinal fusion surgeries. The plaintiffs’ complaints involved fraudulent concealment and misrepresentation, failure to warn, design defect, misrepresentation, negligence, and breach of
Devices
FDA has cleared a Medtronic 510(k) for the StealthStation cranial software as an aid for deep brain stimulation (DBS) lead placement. The software is fully integrated with the company’s latest O-arm Imaging System that helps clinicians with the planning and placement of DBS leads. With Medtronic'
Devices
FDA has cleared a Quidel 510(k) to market its Solana Influenza A+B assay for detecting nucleic acids isolated from nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection to aid in diagnosing Influenza A and B infections. The assay is intended for use only
Devices
Pharmaceutical Research and Manufacturers of America (PhRMA) has filed an amicus brief supporting a request by CCS Medical Supplies that a Massachusetts federal court certify an anti-kickback law decision for interlocutory appeal. The case involves whistleblowers’ claims that CCS, which markets ostomy and continence care products, engaged in “illegal
Devices
FDA has cleared a Roche 510(k) for the Roche Syphilis treponemal antibody test, a fully automated assay for detecting antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments (including the cobas e 411, cobas e 601, cobas e 602
Devices
Rep. Mike Fitzpatrick (R-PA) and several other members of Congress have written a letter to the House Energy and Commerce Committee asking for a hearing to investigate FDA’s “failings” over medical device safety. Fitzpatrick has been a vocal critic of the agency’s handling of laparoscopic power morcellators