On this episode of Voices in Validation we had a chance to speak with former FDA investigator Alan Schwartz about how medical device companies are rising to the challenge to meet demand during this covid-19 pandemic. Additionally we will discuss ways in which the FDA is supporting suppliers and the frontline responders at this critical time.
This is the FDA enforcement policy that is discussed throughout the show. https://www.fda.gov/media/136449/download
- How can we converse masks and respirators while demand is high?
- Will the influx of new masks and respirators be up to FDA standards?
- What is the FDA doing to halt counterfeit respirators?
- Will the quality of medical devices go down during this time?
- Is the US too late to effectively handle the demand?
- What are companies doing to conserve their products right now?
- How does this pandemic effect reliability testing?
- What will be the long term impact on medical device companies?