Episode Thumbnail
Episode 76  |  31:13 min

What You Need to Know About The FDA CDRH Experiential Learning Program

Episode 76  |  31:13 min  |  11.07.2019

What You Need to Know About The FDA CDRH Experiential Learning Program

00:00
00:00
This is a podcast episode titled, What You Need to Know About The FDA CDRH Experiential Learning Program. The summary for this episode is: FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today’s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together. The better the reviewers understand the development processes that medical devices go through, the better they can work effectively with the companies to get medical devices on the market. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Who’s job is it to teach CDRH staff on how medical devices are developed? ● When an FDA visitor is in the building, will the visit be realistic to open and honest discussion? Or filtered and sanitized? ● Visits could work to your advantage. You can “toot your own horn” as a medical device company that has a good regulatory process and sets the bar for quality. ● Skeptics may view the program as a sneaky way for FDA to come in, inspect what’s going on, and force changes - involves companies taking calculated risks. ● CDRH wants to teach staff about certain areas. They should already have subject matter expertise, but may have never been trained. ● CDRH should share information and experiences with medical device companies to improve collaboration without disclosing confidential details. ● Visits offer opportunities for two types of companies: 1) device manufacturers and 2) service providers. ● No good deed goes unpunished. So, make sure you have all your “ducks in a row.” If you want to schedule a visit, there’s a submission deadline of Sept. 26.
FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medical device companies, manufacturers, and service providers to discuss biocompatibility, in vitro diagnostics, clinical trials, and other areas. On today’s episode, Mike Drues of Vascular Sciences and Jon talk about the advantages and disadvantages of this program that encourages reviewers and companies to spend more time together. The better the reviewers understand the development processes that medical devices go through, the better they can work effectively with the companies to get medical devices on the market. SOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE: ● Who’s job is it to teach CDRH staff on how medical devices are developed? ● When an FDA visitor is in the building, will the visit be realistic to open and honest discussion? Or filtered and sanitized? ● Visits could work to your advantage. You can “toot your own horn” as a medical device company that has a good regulatory process and sets the bar for quality. ● Skeptics may view the program as a sneaky way for FDA to come in, inspect what’s going on, and force changes - involves companies taking calculated risks. ● CDRH wants to teach staff about certain areas. They should already have subject matter expertise, but may have never been trained. ● CDRH should share information and experiences with medical device companies to improve collaboration without disclosing confidential details. ● Visits offer opportunities for two types of companies: 1) device manufacturers and 2) service providers. ● No good deed goes unpunished. So, make sure you have all your “ducks in a row.” If you want to schedule a visit, there’s a submission deadline of Sept. 26.

More Episodes

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis

Understanding FDA's New Intended Use Rule and its Implications