FDA Consulting for EUAs and 510(k)s for your PPE and diagnostic tests
The FDA is responding to the national COVID-19 emergency with a tidal wave of new guidance, templates, lists of authorized and removed devices, Daily Roundup updates, town hall meetings, FAQs, etc.
If your head is spinning, we understand that and we can support your FDA compliant path to market.
Our team is experienced in FDA Compiance related to EUAs, 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.
