Advamed updates volume of shipped tests
The Advanced Medical Technology Association (Advamed) said shipments of molecular diagnostic tests in the U.S. had exceeded 150 million as of Sept. 17, a figure derived from the Advamed testing supply registry. The registry, which was announced in July, is updated weekly from the states and from national indicators on the number of molecular and serology tests with an eye toward assisting the U.S. federal government’s response to the COVID-19 pandemic. Scott Whitaker, Advamed’s president and CEO, said roughly 8.5 million tests were shipped weekly in August, up from about 3.7 million in April. Whitaker also said test manufacturers will ship between 32 million and 35 million tests per week in the month of September, and that roughly 100 million antigen tests will have been shipped by the end of autumn.
HHS: Signature memo lessens litigation risk
The U.S. Department of Health and Human Services (HHS) Sept. 20 explained the reasoning behind a memo, issued last week, that requires all rules coming out of the department and any of its agencies to be formally signed by the HHS secretary. Since HHS Secretary Alex Azar has approved all agency regulations in the past, the only change the memo makes is requiring his signature. “Any speculation about this memo being motivated by policy considerations is utterly misinformed,” HHS said, adding that the intent is to minimize the risk of litigation. “Agencies, including HHS, have had rules challenged in court on the grounds that they were signed by officials to whom rulemaking power was improperly delegated,” HHS said. Subsequently, the department conducted a review to ensure its rulemaking procedures were consistent with congressional intent, minimize litigation risk and provide public accountability. The memo is a result of that ongoing review. In accordance with the memo, all rules issued by the department will continue to go through departmental and White House clearance, as they have in the past. They will then be signed by the secretary and the head of the agency involved. HHS clarified that the memo only applies to agency rules; it will not apply to guidance or to the approval or clearance of drugs, vaccines and medical devices.
TGA posts update of non-compliant masks
Australia’s Therapeutic Goods Administration (TGA) has updated its webpage for respirator masks for the that are not in compliance with the agency’s regulatory requirements. Among the triggers for a determination are incorrect Global Medical Device Nomenclature codes, and the use of misleading information regarding the device’s intended purpose. Baoji Taidakang Medical Technology Co. Ltd. was cited for shipping masks labeled as N95 masks despite lacking certification by the U.S. National Institute of Occupational Safety and Health. Other products cited in the update were mislabeled as either surgical masks or surgical respirators, while one product labeled N99 was not qualified as such.