FDA Regulationsfor Emergency Use Authorization (EUA)of Medical Devices & PPE

FDA 510(k) Consulting for EUAs and 510(k)s for your PPE and IVD diagnostic tests

The FDA is responding to the national COVID-19 emergency with a wave of new regulatory guidance, templates, lists of devices that authorized through Emergency Use Authorization (EUA), daily roundup updates, town hall meetings, FAQs, etc.

If you have a product that you would like to bring to the U.S. market through EUA pathway, we understand the FDA’s regulatory Guidance and we can support your FDA compliant path to market.

Our FDA 510(k) Consultants are experienced in FDA regulatory guidance related to PPE &EUAs of medical devices and in vitro diagnostics, NIOSH applications, and 510(k)s for the various COVID-19 response devices including:

  • Ventilators
  • Respirators
  • Masks
  • Face Pieces
  • Gowns
  • Gloves
  • Thermometers
  • Drapes
  • In Vitro diagnostic products such as Antibody, Antigen, and Molecular tests.
We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission