China’s National Medical Products said it will expedite the regulatory review of protective clothing as a response to the coronavirus outbreak. The agency also encouraged manufacturers in China to boost production of protective gear, and promised to expedite the registration of new manufacturing sites for such goods.
Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, said the 2019-nCoV pathogen represents “a very grave threat” for the world outside of China, and that cooperation between nations is thus essential. Ghebreyesus was addressing a meeting of the WHO in Geneva, Switzerland, urging national health authorities to share samples of the so-called Wuhan coronavirus to speed up development of therapies and diagnostics. The comments followed the disclosure that five citizens of the U.K. had contracted the virus after a stay in a hotel with a traveler whose itinerary had included a stay in Singapore. The U.S. Centers for Disease Control and Prevention said in a Feb. 10 statement that another patient in the U.S. has been diagnosed with the coronavirus, bringing the numbers diagnosed in the U.S. to 13. The patient was known to have been in Wuhan, China.
The Medical Device Authority of Malaysia posted a draft guidance for notification of medical device refurbishment activities, the comment period for which closes Feb. 19. The scope of the draft includes any activities that can be described as “substantially rebuilt,” which includes replacement of components that are not appropriate for reuse. The requirements include notification of the unique device identifier number.
Eight members of the U.S. Senate have penned a Feb. 10 letter to FDA commissioner Stephen Hahn urging the FDA to finalize a rule that would ban the use of electrical stimulation devices on patients who have exhibited aggressive or self-injurious behavior. The letter notes that the comment period for the draft rule expired in July 2016, and that more than 1,200 comments appeared in the docket and that the FDA had promised to post a final rule by December 2019. The signers of the letter requested that the agency provide an update by Feb. 28.