Endologix Inc., of Irvine, Calif., reported a correction notice for the Ovation Ix system that identifies the root cause of polymer leaks. The U.S. FDA classified this voluntary action as a class 1 recall. No physical removal of the product is planned or needed. The agency said that the company issued an important safety update Aug. 6, 2018, to customers reporting the polymer leaks were due to incorrect use of the device. By issuing the recall May 6, the company clarified that the root cause for most polymer leaks is a material weakness caused during the manufacturing process. The weakened area may gap or open during use, resulting in liquid polymer leaking outside the device as it is filled. If there is not enough liquid polymer in the device to seal the aneurysm, blood may continue to flow into the aneurysm, requiring additional procedures. Liquid polymer may leak into the patient’s body, leading to serious health consequences, including severe allergic type reactions, unstable blood pressure, tissue damage, organ failure, cardiac arrest, central nervous system problems and death.
The U.S. FDA has posted a warning letter to Klarity Medical Products LLC, of Newark, Ohio, related to an inspection conducted between Feb. 10 and Feb. 25. During the inspection, it was determined that the Klarity Bitelok device is adulterated, as the company does not have an approved application for premarket approval or one for an investigational device exemption. “[Y]our firm considers the addition of the Klarity Bitelok device to be a design change to your firm’s FDA-cleared thermoplastic device (K022708; classified as an accessory to a radiation therapy device under 21 § 892.5050; product code IYE),” the agency wrote. Despite this assertion, the FDA took exception. “We have reviewed your firm’s labeling for the Klarity Bitelok device, your firm’s June 1, 2018, Design Change Assessment, and your firm’s March 6, 2020, response to the FDA 483,” it added. The agency determined that the device in question is different from the thermoplastic mask cleared in K022708 and requires its own premarket notification.
The U.S. FDA finalized its 2018 guidance "Patient-focused drug development: collecting comprehensive and representative input.” It is the first in a series of four guidances intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform the development of medical products and regulatory decision-making. The first guidance presents methods for collecting information on the patient experience that’s representative of the intended population to inform the development and evaluation of medical products throughout the product’s lifecycle. It also discusses methods to operationalize and standardize the collection, analysis and dissemination of patient experience data and includes a glossary of terms that will be used in subsequent guidances in the series.
“Unless substantial changes are made to the way Medicare pays for services and to how beneficiary care is organized and delivered, the cost of the Medicare program will remain on an unsustainable trajectory,” the Medicare Payment Advisory Commission warned this week in its June 2020 report to Congress on Medicare and the health care delivery system. The report urges that serious attention be given to new innovations that would change how hospitals are paid and give providers incentives to manage drug costs. The report also asserts that fee-for-service payment for Medicare services should be replaced by payment to accountable systems of care that have incentives to provide preventive services and early disease detection, avoid delivering unnecessary or inappropriate services, and enhance the use of technologies that improve quality and reduce costs.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a guidance Monday on how it involves the public in its regulatory decision-making. The guidance is part of the agency’s commitment to “delivering a step-change in the way we engage with patients and the public, putting their views and interests at the heart of our decision-making and culture,” the MHRA said. The goal is to adopt a more transparent, responsive and systematic approach to listening to and involving patients and the public.
Warning: some regulatory websites are being targeted by hackers and scammers. Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has put a warning on its website telling users that fake PMDA websites have been found recently. “These websites may steal your information or money or cause any other types of loss or damages,” the PMDA cautioned. The agency also noted that it is receiving many inquiries regarding the licensing and registration of personal protective equipment (PPE) such as surgical masks and N95 respirators for importation, manufacturing and marketing in Japan. The PMDA said it doesn’t issue licenses or certificates for PPE. The website for India’s Central Drugs Standard Control Organisation also appeared to be vulnerable this week, as attempts to access it were met with warnings about attackers potentially stealing information from cdsco.gov.in.
More than a year after the U.S. Court of Appeals for the Federal Circuit reversed a lower court’s grant of summary judgment in Supernus Pharmaceuticals Inc. v. Iancu, the U.S. Patent and Trademark Office (USPTO) is revising the rules of how it determines patent term adjustments in keeping with that precedential ruling. In calculating the adjustment, the USPTO cannot "count as applicant delay a period of time during which there was no action that the applicant could take to conclude prosecution of the patent," the Federal Circuit said in the January 2019 decision involving a Supernus Pharmaceuticals Inc. osmotic drug delivery system patent licensed exclusively to United Therapeutics Corp., of Silver Spring, Md. When determining the patent term adjustment, the USPTO had reduced the adjustment by 646 days due to applicant delay, even though there was nothing Supernus could have done during the 546 days between the filing of its request for continued examination/original information disclosure statement in 2011 and its submission of a European Patent Office notice of opposition, which it didn't receive until 2012. The USPTO’s new final rule will go into effect July 16, according to a notice published in Tuesday’s Federal Register.
The USPTO launched a new program this week to advance the initial examination of applications for trademarks and service marks used to identify qualifying COVID-19 medical products and services. The program is open to applications for products subject to FDA approval for use in the prevention or treatment of COVID-19 or a medical or medical research service to prevent or treat the coronavirus infections. In addition to expediting the examination, the USPTO will waive the fee for the petitions. “Inventors and entrepreneurs are working around the clock to develop products that will help prevent, diagnose, treat or cure COVID-19,” USPTO Director Andrei Iancu said. “Accelerating initial examination of COVID-19-related trademark applications for these products … will help to bring important and possibly life-saving treatments to market more quickly.”