The U.S. FDA posted an enforcement discretion policy for remote digital pathology devices in response to the COVID-19 pandemic, which is designed to expand the availability of devices for remote reviewing and reporting of scanned digital pathology images. The scope of the policy is limited to four product codes, including OEO for automated digital image manual interpretation microscopes, and PZZ for digital pathology displays. The FDA noted that the Centers for Medicare and Medicaid Services had issued a March 26 memo describing that agency’s enforcement discretion for remote viewing of pathology slides and images, and the FDA said it will exercise discretion for modifications to FDA-cleared indications and functionality of both hardware and software to provide for use in remote settings. The agency further said any associated labeling should include amended instructions for use, including to indicate the steps for clinical lab and hospital validation studies when deemed necessary before remote viewing.
The FDA has issued a letter to Bayer AG of Leverkusen, Germany, granting the company a variance for postmarket reporting requirements for the Essure birth control device. The variance covers any information the company becomes aware of from information obtained between November 2016 and November 2020 in connection with litigation regarding the device, assuming that information is obtained via publicly available social media and social media documents. Reportable events within the scope of this variance must be presented in three separate documents, including monthly spreadsheets for any adverse events and an initial form 3500 for each sheet. The agency said the volume of adverse events reported in 2019 is the largest for any single year, but that the source and nature of reports are consistent with those seen in recent years. Bayer said it has retrieved all Essure devices of which it is aware.
France’s National Agency for Medicines and Health Product Safety (ANSM) said in an April 22 statement that it has developed a temporary framework for the use of additive manufacturing to manufacture alternate products needed to address the COVID-19 pandemic. ANSM said manufacturers must test their products for safety and performance prior to introducing them to the marketplace, and that the agency will “very quickly” assess the data. The agency also said it will offer technical assistance to any such entities, many of which are not traditional health care companies.
Sens. Kyrsten Sinema (R-Utah) and Mitt Romney (R-Utah) said in an April 23 letter to the U.S. Centers for Disease Control and Prevention that federal health officials “are behind the curve in assessing public health threat levels” due to a paucity of visible population-level health data. The letter states that a number of public health experts have called for disease monitoring programs based on influenza monitoring and that the latest COVID-19 supplemental provided the agency with $1 billion to be used to construct such a system, which should include aggregate case information from state and local health departments along with hospitalization rates due to the pandemic. Sinema and Romney inquired into any additional resources or authorities needed to erect such a system.