As a result of stakeholder requests, the U.S. FDA has extended the comment period for the public workshop titled “Evolving Role of Artificial Intelligence in Radiological Imaging” to June 30. The agency also has taken several actions this week in its fight against COVID-19. For one, the agency is allowing compounding pharmacies to use hydroxychloroquine to compound human drugs. In moving hydroxychloroquine to category 1 under its interim policy on bulk drug substances that can be used in compounding, the agency said it prioritized the substance due to the coronavirus emergency. Chloroquine phosphate was already a category 1 substance. The agency also issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories. Manufacturers may submit a request to the FDA to have their devices added to the EUA. In addition, the agency announced that as of Thursday, it has issued 16 EUAs for COVID-19 tests that can be used nationwide. The FDA said it has worked with more than 190 test developers who have indicated they will be submitting applications to make tests to detect the virus.

With the ongoing COVID-19 crisis, the U.S. Department of Health and Human Services (HHS) has issued a notice under Executive Order 13910 and section 102 of the Defense Production Act of 1950, designating health and medical resources necessary to respond to the spread of the pandemic that are scarce or the supply of would be threatened by excessive accumulation. The notice was issued March 25 and took effect the same day. The HHS secretary may designate certain resources as scarce materials or materials the supply of which would be threatened by hoarding. The notice has an impact on the following:

  • N-95 filtering facepiece respirators, including devices that are disposable half-facepiece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;
  • Other filtering facepiece respirators, including single-use, disposable half-mask respiratory protective devices that cover the user’s airway and offer protection from particulate materials at an N95 filtration efficiency level;
  • Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
  • Powered air-purifying respirators;
  • Portable ventilators, including those intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas;
  • Drug products with the active ingredient chloroquine phosphate or hydroxychloroquine HCl;
  • Sterilization services for any device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act and sterilizers as defined in 21 CFR 880.6860, 880.6870, and 880.6880, including those that either have FDA marketing authorization or lack such authorization but are intended for the same uses;
  • Disinfecting devices intended to kill pathogens and other kinds of microorganisms by chemical means or physical means;
  • Medical gowns or apparel;
  • Personal protective equipment (PPE) coveralls;
  • PPE surgical masks;
  • PPE face shields; and
  • PPE gloves or surgical gloves