The U.S. FDA has published a list of devices that are in short supply as well as a device that has been discontinued, a fulfillment of related language in the CARES Act of 2020. The agency said the legislation’s revision of Section 506J of the Food, Drug and Cosmetic Act “provides the FDA – for the first time – with authority intended to help prevent or mitigate device shortages,” which was the subject of a guidance in June. The authority is limited to the duration of the public health emergency and to devices and supplies regulated as devices that are critical to patient diagnosis and treatment for COVID-19. The list for shortages includes 20 product codes (procodes), including CBK for continuous ventilators for facility use, FME for examination gowns, and OOI for real-time nucleic acid amplification systems. The sole entry in the discontinuation list is a two-procode entry (FRN and MEA) for infusion pumps, under the Bodyguard line of infusion pumps by Becton, Dickinson & Co., which were the subjects of recalls earlier this year.
The FDA listed a series of device accessory classifications that total seven since the first classification, set forth in April 2018 for the Cartiva synthetic cartilage implant by Cartiva Inc., of Alpharetta, Ga. The Cartiva was the sole accessory classification listed for 2018, and 2019 likewise features only a single classification. The most recent classification is for the TGS universal headrest with mounting arm, a 510(k) product by Stryker ENT of Plymouth, Minn.
Sen. Thom Tillis (R-N.C.) said in an Aug. 10 letter to Andrei Iancu, director of the U.S. Patent and Trademark Office, that two proposals outlined by law professors would optimize inventors’ incentives and reduce unnecessary costs associated with patent prosecution. Tillis had previously sponsored patent reform legislation that failed to gain enough traction for passage in the Senate, although the legislation proposed by Tillis and Sen. Chris Coons (D-Del.) was directed largely to the patent subject matter eligibility question. The first of the reforms proposed by Tillis would be to “more clearly distinguish” hypothetical experimental data from data relating completed experimental/developmental efforts. Such information is ordinarily described in the past or future tense, but Tillis said the tense is not always clear and can be misleading to investors. The second proposal would require holders of patents to record any transactions involving changes of ownership, and to standardize company and individual names to reduce confusion encountered in searchers for prior art. Tillis said these changes would incur no cost to the taxpayer and only minimal administrative cost to the PTO while providing modest savings to applicants.
The U.K. National Institute for Health and Care Excellence said the evidence regarding vagus nerve stimulation (VNS) for treatment-resistant depression (TRD) suggests no major safety concerns, although the literature does suggest “frequent, well-recognized side effects.” The evidence for efficacy is seen as limited in quality, and thus this treatment should be used only in research or when patient data will be entered in a registry. The literature search turned up two randomized, controlled clinical trials (RCTs) and two non-randomized comparative studies, and NICE recommended that the procedure be tried via additional RCTs with either a placebo or a sham arm.
The FDA said its product centers intend to identify entities that have not complied with clinical trial registration requirements by checking whether trials disclosed during inspections are registered in the clinicaltrials.gov database. Any disclosure that suggests non-compliance will be addressed by the individual center, which will send a notice of non-compliance, although this may be preceded by a pre-notice letter that gives the addressee 30 days to respond. The centers will emphasize entities that have a documented history of non-compliance, and will apply a $10,000 penalty for non-compliance. Should the entity in question fail to come into compliance within 30 days following imposition of the penalty, the agency may add another $10,000 penalty for each additional day of non-compliance.
Despite the stage 4 restrictions on businesses recently imposed by the state government of Victoria in Australia due to COVID-19, exemptions will apply to suitably licensed warehouses and distribution centers that are part of Australia’s biopharma supply chain, according to the Therapeutic Goods Administration (TGA). Those exemptions will enable medical supply chains to operate at 100% capacity, assisting with the ongoing supply of medicines and medical devices, including personal protective equipment and medical consumables, within Australia, the TGA said.
As part of its preparation for an annual congressional report, the Office of the U.S. Trade Representative (USTR) is seeking public comment on China’s compliance with the commitments it made when it joined the World Trade Organization in 2001. Topics of interest include China’s practices related to trading rights, import and export regulations, intellectual property rights, transparency, and government policies impacting trade, including subsidies, standards and technical regulations, trade-related investment measures and government procurement practices. The USTR also is asking interested parties to specifically identify unresolved compliance issues that warrant review and evaluation by the office’s China Enforcement Task Force, according to a notice to be published in Tuesday’s Federal Register. Comments should be submitted to Docket Number USTR-2020-0033 by Sept. 16.
The U.S. Court of Appeals for the Ninth Circuit found for a plaintiff in the ongoing lawsuit over inferior vena cava (IVC) filters made by C.R. Bard Inc., of Murray Hill, N.J., dismissing a preemption argument made for a class II device. The case was on appeal from Arizona district court as part of the Bard IVC filters multidistrict litigation operating under Georgia state law, and counsel for Bard argued preemption despite that the G2 IVC filter is regulated by the FDA as a class II device. That approach failed because the plaintiff’s claim revolved around state law duty to warn of the risks associated with the G2 filter, and the court noted that the FDA had not imposed “any requirements related to the design of that device or how a device of that design should be labeled.” Bard also said the district court judge had erred in not granting summary judgment regarding the plaintiff’s negligent failure-to-warn claims, arguing that Georgia state law does not recognize a duty to warn patients of the comparative risks posed by different devices, but the court responded that the courts in Georgia had not adopted any categorical prohibitions of failure to warn claims based on a lack of comparative warning. The three-judge panel also ruled against the company’s reasserted motion for judgment as a matter of law regarding punitive damages, an argument the court said was “largely derivative” of the argument that the company had no duty to warn of comparative risks.