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

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

How Mindset Training Can Help Your Team Operate at Peak Performance

Examining the HHS Proposal for Premarket Notification Exemptions

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Building your Brand as a Medical Device Professional