Podcasts

Testing

Mike on Medtech: Human Factors/Usability, Part 2

Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.

Sean Fenske, Editor-in-Chief 02.03.20

Testing

Mike on Medtech: Human Factors/Usability, Part 1

Mike Drues and Sean Fenske discuss the importance of human factors within the regulatory landscape and how it came to matter to FDA.

Sean Fenske, Editor-in-Chief 02.03.20

Mike on Medtech: Change Management, Part 2

Mike Drues and Sean Fenske discuss the potential implications for a medical device manufacturer who mishandles the reporting of a change to a device.

Sean Fenske, Editor-in-Chief 01.20.20

Mike on Medtech: Change Management, Part 1

Mike Drues and Sean Fenske discuss the procedures and best practices for handling change management for a variety of potential revisions to a device.

Sean Fenske, Editor-in-Chief 01.20.20

Mike on Medtech: Safety and Performance Based 510(k)

Mike Drues and Sean Fenske discuss an “abbreviated” 510(k) option for specific, well-understood devices that doesn’t use a predicate.

Sean Fenske, Editor-in-Chief 12.05.19

Mike on Medtech: The Special 510(k) Program

Mike Drues and Sean Fenske discuss a 510(k) option for modifications to a company's legally marketed medical device.

Sean Fenske, Editor-in-Chief 11.13.19

Mike on Medtech: Beyond 510(k)/PMA—Safer Technologies Program

Sean Fenske and Mike Drues discuss another new program from the FDA—the Safer Technologies Program (STeP)—and the details of it.

Sean Fenske, Editor-in-Chief 10.17.19

Mike on Medtech: Benefit-Risk Determinations

Sean Fenske and Mike Drues discuss two FDA guidance documents that focus on considerations and uncertainty in making benefit-risk determinations.

Sean Fenske, Editor-in-Chief 09.16.19

Mike on Medtech: Beyond 510(k)/PMA—Breakthrough Devices Program

Sean Fenske and Mike Drues discuss a relatively new program from the FDA—the Breakthrough Devices Program—and what it offers to medtech manufacturers.

Sean Fenske, Editor-in-Chief 08.06.19

Mike on Medtech: Beyond 510(k)/PMA—De Novo 101

Sean Fenske and Mike Drues discuss the third most common regulatory pathway—the De Novo—clearing up details about its advantages and when it's used.

Sean Fenske, Editor-in-Chief 07.02.19

Mike on Medtech: The NYT Editorial Board Statement

Sean Fenske and Mike Drues discuss the recent comments made by the Board about the medical device industry and FDA.

Sean Fenske, Editor-in-Chief 06.17.19

Mike on Medtech: The Alternative Summary Reporting Program

Sean Fenske and Mike Drues discuss the recently announced cancellation of the alternative summary reporting program and the reasons for it.

Sean Fenske, Editor-in-Chief 05.24.19

Mike on Medtech: A Pre-Sub for 483s, Part 2

Sean Fenske and Mike Drues continue a discussion regarding a recently released FDA guidance focused on communication with the agency over a 483.

Sean Fenske, Editor-in-Chief 05.09.19

Mike on Medtech: A Pre-Sub for 483s, Part 1

Sean Fenske and Mike Drues discuss a recently released FDA guidance that outlines a specific communication protocol to address certain 483s with the agency.

Sean Fenske, Editor-in-Chief 05.09.19

Materials