Three members of the U.S. Senate asked the FDA whether the agency has identified the type of data or evidence that will be used to demonstrate compliance with the excellence appraisal for the digital pre-certification program for software as a medical device. The three senators, Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.) and Tina Smith (D-Minn.), had inquired into the pre-cert program in October 2018, and were responding to the FDA's June 2019 response to that initial formal communique. Among the latest questions posed by the senators was whether the agency has gained additional clarity on how it will "appropriately limit" the flexibility it will grant sponsors in demonstrating excellence under the excellence appraisal mechanism. The letter requests copies of mock excellence appraisals under the pre-cert pilot and inquired into which elements of the excellence appraisal might have to be separated or removed from the appraisal process. The authors of the letter noted that the incorporation of the de novo process into the program "is notably distinct from the process outlined" in the December 2018 proposed rule, and asked whether the agency believes that Congress intended that the de novo path be used to establish a pilot program "that fundamentally alter[s] the FDA's existing method of device review and approval." Other questions posed in the letter to the FDA revolve around postmarket surveillance and the absence of any mention of the pre-cert pilot in the December 2018 draft rule for de novo petitions.
The U.S. Agency for Healthcare Research and Quality (AHRQ) said it is seeking supplemental evidence to inform its ongoing review of interventions for dyspnea in patient with advanced cancer. The review is undertaken to determine the comparative benefits of both pharmacological and non-pharmacological therapies for patients at least 18 years old, and includes mechanical airway support devices (CPAP and BiPAP) and neuromuscular electrical stimulation. AHRQ is taking submissions through Nov. 31.
The U.S. Substance Abuse and Mental Health Services Administration said two labs are voluntarily withdrawing from the list of clinics that are certified by the agency to conduct urinary drug testing for federal workplace drug testing programs. The labs in question are the Baptist Medical Center toxicology lab in Little Rock, Arkansas, and ACM Medical Laboratory Inc., of Rochester, N.Y.
The U.S. Environmental Protection Agency (EPA) has missed a self-imposed deadline to issue an advance notice of proposed rulemaking (ANPR) for ethylene oxide emission, a deadline the agency announced in a Sept. 13 statement. EPA said it was taking a two-pronged approach to the EtO emissions question, including the issuance of the ANPR that would outline the approaches the agency might take to an impending rule on EtO emissions. That document was due in October, but no such notice has emerged either in the Federal Register or at the EPA website. Another requirement toward development of a final rule is the issuance of a request for information to "several commercial sterilization companies," the agency said, for data on specific facility characteristics, control devices and the costs associated with installation and operation of emission-reduction measures. EPA is also procedurally liable for assessing the impact on small businesses as one-third of the sterilizer companies that would be affected by the rule are small businesses.
The European Commission said the European database on medical devices (Eudamed) will not be fully operational until May 2022 due to the need to integrate the various modules and ensure they are functional. This date is two years later than the compliance deadline for non-IVD devices, for which the new regulatory framework is in force in 2020, but the EC noted that the compliance deadline for those devices has not changed despite the delay in standing up the second iteration of Eudamed. The Commission noted that the database must also go through rigorous outside audit before the revised database can go live. May 2022 is also the date at which makers of IVDs must be in compliance with the IVD regulations.