Devices
FDA has posted a final guidance entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The guidance complies with section 702(b)(2) of the FDA Reauthorization Act of 2017, which directs it to issue guidance that specifies how the agency will implement uniform processes and standards that
Devices
Chengdu Ai Qin E-commerce Co. has recalled its colored contact lenses after FDA notified the firm that they were distributed without agency clearance and may pose a threat to health. The devices were sold through the Web site www.ttdeye.com and shipped directly to customers. The recalled products
Devices
FDA has cleared a Ekso Bionics 501(k) for the EksoNR robotic exoskeleton for use with patients with acquired brain injury (ABI). The device was previously cleared for stroke and spinal cord injury rehabilitation in 2016. The company says that ABI is the broadest category of brain injury and comprises
Drugs
An online post explains how FDA is building on its more than a decade of experience in working with the European Commission and its European Medicines Agency (EMA) to collaborate on several scientific and regulatory fronts as part of the Covid-19 response. The paper says that what has helped
Devices
FDA has approved a Medtronic PMA for the Percept PC Deep Brain Stimulation (DBS) system for treating patients with neurologic disorders associated with Parkinson's disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder. DBS is an individualized therapy delivered from a small pacemaker-like device, placed under the
Devices
FDA has qualified the Insulin Dosing Systems Perceptions. Ideas, Reflections, and Expectations (INSPIRE) questionnaires through the Medical Device Development Tools (MDDT) program. Once qualified, an agency notice says, the INSPIRE questionnaires can be used to qualitatively assess the impact of automated insulin dosing (AID) systems to manage Type 1 diabetes
Devices
FDA has granted preCardia, Inc., a breakthrough device designation for its catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF). The device is intended to rapidly reduce congestion in the venous system, known as cardiac preload, thereby improving overall cardio-renal function, the company
Devices
FDA says it is not aware of an antibody test that has been validated for diagnosing SARS-CoV-2 infection. Writing in a special MedWatch safety alert, the agency says that while it remains open to receiving the submission of tests for such use, based on the underlying scientific principles
FDA Policy/General
FDA commissioner Stephen Hahn says the agency “has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.” Writing in an online post to praise agency staff for their efforts, Hahn says FDA is on
Devices
FDA has approved a Mainstay Medical Holdings PMA for ReActiv8, an implantable neurostimulation system to treat intractable chronic low back pain. Approval was based on clinical data demonstrating that the device therapy provides “progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of
Devices
Hyman, Phelps & McNamara has asked FDA to provide examples to clarify specific items in the agency’s draft guidance on “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.” The draft guidance focuses on emergency-use injectors marketed with a drug/biological
Devices
FDA has issued a safety alert on hand sanitizers manufactured by Eskbiochem SA de CV in Mexico due to the potential presence of methanol (wood alcohol), which can be toxic when absorbed through the skin or ingested. The alert identifies nine products manufactured by Eskbiochem that contain methanol. “Consumers who
Devices
FDA has issued a guidance on “Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers.” The document says that CDRH is leveraging technology to host teleconferences and video conferences rather than in-person meetings with industry during the
Devices
FDA has updated a guidance entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency.” The document was updated to include a list of device types and corresponding product codes
Devices
[Report by David McFarland) FDA is learning fast that relaxing its standards during the Covid-19 pandemic causes many problems that it now struggles to contain and correct. The first troubles began with Covid-19 testing after FDA allowed testing laboratories and various manufacturers market access with minimal data and
Devices
FDA has approved the expansion of a USGI Medical pilot study of it endoscopic procedure known as POSE 2.0. The study is designed to evaluate weight loss for adults suffering from obesity with a body mass index (BMI) of 35 to 40 kg and an obesity-related comorbidity, such
Devices
FDA has approved a 300 mg single-dose pre-filled pen for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab). The pre-filled pen is approved for all Dupixent indications in patients aged 12 years and older, which includes at-home administration for atopic dermatitis, asthma and chronic rhinosinusitis with nasal
Devices
FDA-backed Critical Path Institute’s (C-Path) Transplant Therapeutics Consortium (TTC) has submitted the iBox Scoring System for CDER’s Biomarker Qualification Program. TTC provided information supporting the qualification of the iBox Scoring System as a reasonably likely surrogate endpoint for clinical trials evaluating immunosuppressive therapies for use in
Devices
FDA says it is participating in the Covid-19 Diagnostics Evidence Accelerator, described as a multi-stakeholder project to advance the development of diagnostics. An online notice says the accelerator is organized by the Reagan-Udall Foundation in collaboration with Friends of Cancer Research. The notice says the Diagnostics Evidence
Devices
FDA has approved the expansion of a U.S. pilot study of the USGI Medical POSE 2.0 non-invasive endoscopic procedure to evaluate weight loss for adults suffering from obesity and an obesity-related comorbidity. The company says POSE 2.0 uses the USGI incisionless operating platform to strategically
Devices
FDA has posted template updates for the validation of molecular diagnostic tests to be used by developers who intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having Covid-19. An agency online statement says the template updates are “a meaningful
Devices
FDA has revoked the emergency use authorization of Chembio Diagnostic System’s antibody test, DPP Covid-19 IgM/IgG System, due to performance concerns with the accuracy of the test. The serological test, which is intended to assess a person’s exposure to Covid-19, was one of the first