The U.S. Department of Health and Human Services posted a request for information related to temporary regulatory actions taken by HHS agencies that could be made permanent after the current public health emergency has expired. HHS said the request is a response to Executive Order 13924, and provides a list of actions undertaken in response to the COVID-19 pandemic, including enforcement discretion in connection with telehealth services. The department stated that some of the changes made in response to the pandemic will remain temporary, while others may be made permanent, with or without changes. The memo is dated Nov. 5 despite being posted in the Federal Register Nov. 24. Among the regulatory actions up for review under this RFI are FDA enforcement policies for articles such as medical imaging systems and face masks and respirators, along with enforcement policies related to the conduct of clinical trials. HHS is taking comment through Dec. 24, 2020. HHS also posted a notice regarding public access to materials used at the department to conduct impact analyses of federal regulations. The scope of the policy covers all working papers, modeling exercises and other work product associated with the underlying policy.
FDA lists entities recognized under ASCA program
The U.S. FDA posted a list of five bodies recognized to take part as testing lab accreditation entities for the agency’s Accreditation Scheme for Conformity Assessment (ASCA) program, each with an expiration date of Sept. 30, 2022. One of the accreditation organizations, the National Voluntary Laboratory Accreditation Program by the National Institute for Standards and Technology, accredits only for basic safety and essential performance. The remaining four entities offer accreditation of testing labs for biocompatibility and for basic safety/essential performance.