How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?
Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic?
In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.”
Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.
Some highlights of this episode include:
- Mr. Regulatory’s YouTube Channel posts videos that cover new and old FDA guidance and regulations that are meaningful, applicable, and relevant.
- New FDA policies may drive discussions and gain different perspectives on EUAs by finding ways to navigate bandwidth and prioritize timelines.
- Current Crisis: For the FDA to handle and keep up with EUA requests, it’s open to suggestions and responsive regarding technologies and products.
- Regulatory ramifications, side effects, and far-reaching implications of digital strategies and policies do not involve a simple rollback of software.
- New Normal/Status Quo: FDA engaging in data collection and digital health to make decisions. FDA doesn’t intend to object, but use enforcement discretion.
- Pros/Cons of Caveats: How can devices/studies be monitored remotely to maintain safety and achieve efficacy endpoints by following protocols?
- 21 CFR Part 820 vs. ISO 13485: During the pandemic, should the FDA waive compliance requirements to address potential issues, such as device shortages?
- Harmonization: U.S. FDA’s alignment and operations with Health Canada is expected to continue. Congress may need to get involved at some point, as well.
Memorable quotes from this episode:
“(FDA) They’re definitely open to finding ways to navigate the path forward.” David Pudwill
“Once the cat’s out of the bag, it’s really hard to reverse this.” David Pudwill
“How do we appropriately monitor studies remotely and make sure that we’re maintaining safety and achieving efficacy endpoints because we are following the protocol robustly?” David Pudwill
“They retain the ability to enforce the regulation if they change their mind...but they have no intention of doing so.” David Pudwill