FDA blasts thermographic sensor system marketers
The U.S. FDA has posted several warning letters to companies marking temperature scanners and thermal imaging devices for the COVID-19 pandemic, including the March 4 warning letter to Cantronic Systems Inc., of Coquitlam, British Columbia, for several of the company’s products, including the Feverscan 3000. These devices do not enjoy a conventional premarket review for marketing in the U.S., the agency said, adding that claims that the systems are able to provide mass scanning violate the agency’s pandemic policy for thermal scanning systems. Also receiving warning letters are the Workswell Group S.R.O., of Prague, which the agency cited for its Medicas system, and Westminster International Ltd., of Oxfordshire, U.K., for the WG520 and WG620 systems. Omnisense Systems Inc., of Fort Lauderdale, Fla., similarly was cited in a March 4 warning letter for its Sentry MK4 system. The FDA had previously announced it was acting on what it believes is inappropriate marketing of such systems.
WHO to tackle breast cancer globally
The World Health Organization (WHO) introduced its Global Breast Cancer Initiative March 8 with the goal of reducing global breast cancer mortality by 2.5% per year until 2040, thereby saving about 2.5 million lives. The initiative will focus on public education, timely diagnosis and comprehensive treatment. Although breast cancer survival five years after diagnosis exceeds 80% in most high-income countries, WHO said it is much lower in other countries. For instance, five-year survival rates are 66% in India and 40% in South Africa. Treating breast cancer has become more of a priority now that it has overtaken lung cancer as the world’s most commonly diagnosed cancer and is responsible for 1 in 6 of all cancer deaths among women.
PhRMA urges Biden to stand by IP rights
Amid reports that the Biden administration might be rethinking its support of a proposal to suspend critical intellectual property (IP) provisions of the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, the Pharmaceutical Research and Manufacturers of America (PhRMA) wrote to President Joe Biden last week urging him to continue to stand with Brazil, Canada, the EU, Japan, Norway, Switzerland and the U.K. in opposing the waiver. The proposal, led by India and South Africa, would waive “protection and enforcement of copyrights, industrial designs, patents and trade secrets on any COVID-19 innovation until widespread vaccination is in place globally,” PhRMA said. It added that there’s no evidence to support the sponsors’ claim that IP “is hindering the global response to the pandemic and that the waiver would help scale up research, development, manufacturing and supply of needed products.” Instead, the trade group said, IP has been the foundation to speed R&D of COVID-19 treatments and vaccines and to facilitate technology sharing needed to scale up manufacturing.
FDA ASCA workshop announced
The U.S. FDA announced it will hold an April 13 workshop on the use of reference standards as part of the Accreditation Scheme for Conformity Assessment (ASCA) pilot. The ASCA program is directed to the use of testing labs that are accredited by third parties to perform testing of medical devices, and the two-hour workshop will focus first on the use of consensus standards in premarket submissions. The second of the two hours will take up methods for streamlining conformity assessments in device submissions. No registration is required, the FDA said.