Episode Thumbnail
Episode 34  |  34:02 min

2016 Medical Device Regulatory Trends Year in Review

Episode 34  |  34:02 min  |  11.07.2019

2016 Medical Device Regulatory Trends Year in Review

00:00
00:00
This is a podcast episode titled, 2016 Medical Device Regulatory Trends Year in Review. The summary for this episode is: We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On today’s episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review. Some of the topics you’ll hear discussed include: - Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers. - Two guidances on when to submit a 510K and why these in particular are important. - General wellness devices: What they are and what makes them different from regulated devices. - Thoughts on the Use of Real-World Evidence guidance document. - Why the guidance on 3D printing is so impactful. - What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability. - Thoughts on whether the FDA should be in the business of putting out guidance documents.
We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On today’s episode, Mike Drues and Jon go over the many happenings in the medical device industry over the past year. Mike is a frequent guest on our show, and today we will be talking about the year in review. Some of the topics you’ll hear discussed include: - Some of the significant guidance documents that were new in 2016, including one on medical device reporting for manufacturers. - Two guidances on when to submit a 510K and why these in particular are important. - General wellness devices: What they are and what makes them different from regulated devices. - Thoughts on the Use of Real-World Evidence guidance document. - Why the guidance on 3D printing is so impactful. - What might happen from a regulatory perspective in 2017, including more specific guidances and focusing on usability. - Thoughts on whether the FDA should be in the business of putting out guidance documents.

More Episodes

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Understanding the UDI System for Medical Devices

Understanding the UDI System for Medical Devices

Shaking Things Up: What's Next for the Global Medical Device Podcast

Shaking Things Up: What's Next for the Global Medical Device Podcast

How Augmented Reality (AR) is Revolutionizing Healthcare

How Augmented Reality (AR) is Revolutionizing Healthcare

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care