Devices
The Department of Justice says Advanced Bionics, a Valencia, CA, manufacturer of cochlear implant system devices, will pay more than $12 million to resolve a whistleblower’s allegations that it misled federal healthcare programs about the radio-frequency (RF) emissions generated by some of its processors. A department statement says
Devices
FDA has cleared a Providence Medical Technology Cavux Facet Fixation System (FFS) for spinal surgery patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. FFS is an integrated cage and screw system that is implanted bilaterally in
Drugs
FDA has published a draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, to define the types of behaviors (actions, inactions, or circumstances) that FDA considers to be delaying, denying, or limiting an inspection, or refusing to permit entry or inspection for the purposes
Devices
AdvaMed says it supports FDA efforts through a draft guidance to update the breakthrough devices program. The association’s comment letter says it strongly supports FDA efforts to clarify how the program may apply to medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly
Devices
Attorneys Gail Javitt and Jeffrey Gibbs (Hyman, Phelps & McNamara) say the “grandfathering” provision in the proposed VALID Act to regulate laboratory-developed tests (LDTs) could adversely affect in-home specimen collection used in telehealth applications. Writing in their firm’s FDA Law Blog, the two say it does not
Devices
FDA has cleared a Life Spine 510(k) for the TruLift Lateral Expandable Spacer System and Lateral Plate System for use in lumbar interbody fusions. The titanium expandable interbody TruLift Lateral is offered in a range of sizes and footprints and can be expanded to the desired height (8mm to
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says it appears that FDA issued a 7/29 guidance on LASIK laser patient labeling in an attempt to “induce manufacturers to seek approval of a labeling change, and to direct them as to what changes they should request.” Writing in his firm’
Devices
FDA has cleared a Bausch + Lomb 510(k) for its Biotrue Hydration Boost Contact Lens Rehydrating drops, a preservative-free multi-dose rehydrating drop for use with soft and rigid gas permeable contact lenses. The drops contain a “combination of ingredients informed by the Tear Film and Ocular Surface Society&
Devices
The Physicians Committee for Responsible Medicine (PCRM) is asking FDA to open an inquiry into Elon Musk’s Neuralink brain implant company. PCRM says Neuralink should be investigated for possible violations of good laboratory practice (GLP) regulations. The company is already facing Department of Agriculture and Department of Justice probes.
Devices
Smiths Medical has issued an “urgent medical device correction” letter identifying two potential issues with CADD Infusion System Infusion Sets related to lack of delivery or underdelivery and false “no disposable attached (NDA)” alarms. The letter details the issues, the affected items, the required steps to perform, and specific instructions
Devices
A 12/12 JAMA viewpoint article is urging FDA to appropriately test for readability and general literacy its breast density notification language that is part of an upcoming rule that was mandated by the 2019 Breast Density and Mammography Reporting Act. The rule would require providers to include mandatory statements
Devices
FDA has updated its device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC). The gloves were placed on the list during the early pandemic days. Affected products include latex patient examination gloves, vinyl patient examination gloves, polymer patient examination gloves, and specialty patient examination gloves.
Devices
A 3/3/22-3/25/22 FDA inspection at Empowered Diagnostics, Pompano Beach, FL, found that the firm manufactures and distributes several Covid-19 tests that have not received marketing approval, clearance, or authorization from FDA. A just-released 10/6/22 Warning Letter said some of the kits
Devices
Remel is recalling (Class 1) Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with the following antibiotics: Carbapenem (doripenem, ertapenem, meropenem, imipenem), cefepime, piperacillin/tazobactam, and aztreonam. The in
Devices
FDA has published “Report on Risks and Benefits to Health of Non-Device Software Functions — December 2022.” An agency notice says the report “highlights FDA’s Digital Center of Excellence findings on the five software functions excluded from the device definition by the 21st Century Cures Act.” The functions range
Devices
FDA has published a draft guidance, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers, to help manufacturers better understand and use the VMSR program. The document says it is to further explain, but not change, the conditions of the VMSR program. The guidance describes and clarifies several aspects of the
Devices
FDA has published a draft guidance, Content of Human Factors Information in Medical Device Marketing Submissions, with recommendations for the content of human factor and usability engineering information to be included in marketing submissions. The document says a marketing submission should, where appropriate, demonstrate that the needs of the intended
Devices
Dewei Medical Equipment has recalled its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA authorization, clearance, or approval. “This means there is a risk for false negative, false positive, or misinterpretation of results if these products are used to detect SARS-CoV-2
Devices
FDA has denied a petition submitted on 12/11/2020 by attorney James Czaban (Loeb & Loeb) asking that the agency “clarify and confirm circumstances … under which garments generally known as ‘scrubs,’ which are worn as daily-wear uniforms by a wide variety of employees in various healthcare settings, are
Devices
CDRH researchers say the medical device shortage early reporting requirements included in the CARES Act facilitated early identification and mitigation of device shortages during the Covid-19 pandemic. Writing in Health Affairs, they say (purchase required) that outside of public health emergencies, the agency does not have the regulatory authority
Drugs
The Coalition for Health AI has released a summary of meetings held by experts across a dozen institutions, with observers from FDA and other stakeholders, working through issues that would need to be addressed for enabling trustworthy artificial intelligence (AI) in healthcare. “This work summarizes those discussions as a step
Devices
Former FDA commissioners Scott Gottlieb and Mark McClellan say Congress should act promptly to approve the Verfiying Accurate Leading-edge IVCT Development Act (VALID Act) and modernize FDA’s regulatory framework for overseeing diagnostic tests that are used to screen blood and tissue. Writing in an online Stat News opinion