Devices
FDA has published a guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, with its recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance environment and the recommended format for magnetic resonance imaging safety information in medical device
Devices
FDA has published a guidance, Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages, extending to 9/24/23 the enforcement discretion date by which the agency does not intend to object to the use of legacy FDA identification
Devices
FDA says antibody tests should not be used at this time to determine immunity or protection against Covid-19, especially after a person has received a Covid-19 vaccination. A just-posted safety communication says: * The authorized Covid-19 vaccines induce antibodies to specific viral protein targets; post-vaccination antibody
Devices
FDA has published an updated final guidance, Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] Submissions, with recommendations for 510(k) submissions for these devices. The document says the recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions. In
Devices
FDA has published a guidance, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation—Non-clinical Testing and Clinical Considerations, with recommendations for Q-submission and IDEs for implanted brain-computer interface (BCI) devices for patients with paralysis or amputation. The document says that because CDRH believes
Devices
FDA has published a draft guidance, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus, with study recommendations for these devices. The document says that while several legally marketed medical devices help patients manage Type 2
Drugs
International business management consultancy Sedgwick says that while product recalls, including drugs and medical devices, have dropped during the pandemic, there is likely to be a surge in recalls as businesses return to more normal operating conditions. In a statement, Sedgwick says that in the first quarter of 2021, medical
Devices
The Pew Trusts says the Covid-19 pandemic has demonstrated the value in FDA reviewing laboratory-developed tests (LDTs) and says Congress should adopt reform legislation that would maintain the agency’s central role in overseeing diagnostic tests. An online paper says the agency’s regulatory authority over tests remains
Devices
FDA says it has posted the ninth spreadsheet of reportable adverse events submitted by Bayer for its withdrawn Essure birth control device. The latest spreadsheet covers February of this year, FDA says (contains link to all spreadsheets). The notice also says Bayer posted its third quarterly analysis report of adverse
Devices
CDRH expects to release by the end of the year an updated draft guidance on medical device cybersecurity premarket submission recommendations. Speaking at a 5/13 FDA/Xavier MedCon conference, CDRH cybersecurity policy analyst Matthew Hazelett said the 2018-released draft on Content of Premarket Submissions for Management of Cybersecurity
Devices
FDA has approved a Zoll Medical IDE for a randomized prospective study evaluating the use of TherOx SuperSaturated Oxygen Therapy in patients presenting with ST Elevation Myocardial Infarction (STEMI) and cardiogenic shock and treated concurrently with a mechanical circulatory support device. Patients presenting with STEMI and cardiogenic shock typically have
Devices
The House Energy and Commerce Committee leadership has written to HHS secretary Xavier Becerra urging that he reverse the Trump administration HHS decision to remove FDA authority to require premarket review of Covid-19 laboratory-developed tests (LDTs). The 5/11 letter says that at the time former HHS secretary
Devices
FDA is advising pacemaker and other electronic implant device wearers to keep their cell phones, smart watches and other electronic devices at least six inches away from their implants due to magnetic interference concerns. The safety advisory notes that some consumer electronic devices (cell phones, smart watches) may contain high
Devices
FDA says an Abbott (St. Jude Medical) 3/15 recall of a subset of Assurity and Endurity pacemakers is Class 1. An agency notice says Assurity and Endurity are implantable bradycardia pacemakers. The notice says the company recalled a subset of the pacemakers distributed from 4/2015 to 2/2019
Devices
CDRH director Jeff Shuren believes FDA will likely favor a “hybrid” inspection program going forward in the post-Covid-19 world, relying both on in-person and interactive online assessments. Speaking last week at an FDA/Xavier MedCon conference, Shuren acknowledged the pandemic’s disruption on inspecting manufacturing facilities. “We
Devices
FDA says the Medtronic 2/26 recall of the instructions for use and patient manual for its HeartWare HVAD (HeartWare Ventricular Assist Device) system is Class 1. An agency announcement says Medtronic recalled the system to provide updated instructions for use and patient manual due to safety issues with the
Devices
FDA has approved a Johnson & Johnson Vision PMA for its Acuvue Abiliti Overnight Therapeutic Lenses, the first orthokeratology contact lens for managing myopia. Approval was based on data demonstrating that the lenses can be a safe and effective treatment option to manage myopia, according to the company. They are
Devices
FDA has cleared a Desktop Health 510(k) for its Flexcera Base, a proprietary resin for use in 3D fabrication of dental prosthetics. Flexcera was developed with the strength of ceramic coupled with long-chain chemistry to ensure optimal denture properties, the company says. “When used exclusively with EnvisionTEC 3D
Devices
FDA says the Web site maintained by Anytime Covid Test LLC, Boynton Beach, FL, indicates the firm is marketing a direct-to-consumer Covid-19 test kit that is legally considered a medical device. A just-released 4/13 Warning Letter says the kit is being offered without marketing approval,
Devices
FDA has awarded breakthrough device status to Avenda Health for a male “lumpectomy” product being developed to treat prostate cancer in-office. The company says its focal therapy system uses patient-specific information and artificial intelligence to deliver a precise and personalized treatment targeting only the tumor. Under the breakthrough
Devices
FDA has cleared a Bolder Surgical 510(k) for an expanded indication for the CoolSeal Trinity 5 mm Laparoscopic Vessel Sealer, Divider, and Dissector to include surgical procedures for pediatric patients including infants, children, and adolescents. “The larger vessel sealing capacity and cutting functionality of CoolSeal Trinity complements the 3
Devices
FDA has granted Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its next-generation artificial intelligence (AI) platform for use in early detection of oral and throat cancer. The device uses saliva as a “liquid biopsy” to analyze samples for the presence of oral squamous