The U.S. FDA posted an enforcement policy for digital devices used to treat psychiatric disorders during the COVID-19 pandemic in an effort to expand availability of such products. The agency will exercise enforcement discretion for computerized behavioral therapy devices and other digital health offerings for psychiatric disorders if such distribution does not create undue risk for the end user. The FDA does not regulate software for video conferencing, and the scope of the conditions to which this policy applies includes obsessive compulsive disorder, major depressive disorder, post-traumatic stress disorder and attention deficit-hyperactivity disorder. The patient need not have been diagnosed prior to the onset of the COVID-19 pandemic. The agency suggests that developers perform the standard software verification, validation and hazard analysis activities such as are included in Part 820, and that cybersecurity protections be included per the agency’s pre- and postmarket cybersecurity recommendations. The policy also governs low-risk general wellness products.

Building on its existing policy regarding the labeling of companion diagnostics, the U.S. FDA issued a guidance discussing the development and labeling of in vitro companion diagnostics to support the use of multiple oncology drugs. “Trials designed to support approval of a specific therapeutic product and a specific companion diagnostic have led to companion diagnostic labels that reference only a specific therapeutic product(s). Such specificity in labeling can limit a potentially broader use of a companion diagnostic that may be scientifically appropriate,” according to the agency. The guidance discusses considerations for developing a companion diagnostic for labeling for use with a specific group of oncology products and for broadening the labeling of already approved or cleared companion diagnostics.

The U.S. Federal Trade Commission said it has sent another 10 warning letter to domestic and other companies in connection with unsubstantiated claims that the targets’ product can treat or prevent “coronavirus disease.” Many of the recipients are makers of nutritional supplements, but the April 8 letter to Face Vital LLC, of Miami Beach, Fla., addresses the company’s promotion of a sonic silicon face brush, which would be used to “fight off corona.” The agency previously advised VOIP providers that it is illegal to aid in or facilitate the transmission of prerecorded robocalls that promote unproven products associated with the COVID-19 pandemic.

The Advanced Medical Technology Association (Advamed) said in an April 15 statement that executives from a number of med-tech firms have been appointed to the White House task force designated to provide recommendations on how to safely reopen the U.S. economy with the COVID-19 pandemic still at large. “[T]he inclusion of so many med-tech community leaders on this key White House task force speaks to the important role our industry will play in getting America back to work,” said Scott Whitaker, Advamed’s president and CEO. He added that the med-tech execs named to the task force “have decades of experience in getting crucial devices and diagnostics into the hands of those who need them, and the country will be well served by their expertise.” Among those named to the task force are Mike Kaufmann, CEO of Cardinal Health, of Dublin, Ohio, and Marc Casper, board chairman and CEO of Thermo Fisher Scientific Inc., of Waltham, Mass.

The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) said it is supporting regulatory flexibility for companies in the U.K. in an effort to scale up testing capacity for the COVID-19 pandemic. Among the policy documents posted is one directed toward serological testing kits and platforms, for both professional and at-home use. The MHRA said it seeks proposals that would support reliable and accurate antibody testing with technologies that are “scalable, resilient, and scientifically robust.”

No Comments