Mr. Regulatory
ATTN: DOGE and RFK Jr: Three ways FDA has resisted government oversight over the past seven years
10:27
Mr. Regulatory
Talking About Life And What To Expect From The Upcoming Administration with The Fourth Way
1:28:34
Mr. Regulatory
David's Corporate Medical Device Experience
3:46
Mr. Regulatory
Office Hours with David Pudwill - UCSD Regulatory Submissions for Medical Devices on August 1, 2024
48:36
Mr. Regulatory
Office Hours with David Pudwill - UCSD Regulatory Submissions for Medical Devices on July 26, 2024
58:21
Mr. Regulatory
Office Hours with David Pudwill - Ask a Former FDA Reviewer - July 18, 2024
1:08:08
Mr. Regulatory
Office Hours with David Pudwill - UCSD Regulatory Submissions for Medical Devices on July 18, 2024
37:52
Mr. Regulatory
Office Hours with David Pudwill - UCSD Regulatory Submissions for Medical Devices on July 11, 2024
49:32
Mr. Regulatory
Office Hours with David Pudwill - UCSD Regulatory Submissions for Medical Devices on July 4, 2024
1:01:18
Mr. Regulatory
Office Hours with David Pudwill - UCSD Regulatory Submissions for Medical Devices on June 29, 2024
51:08
Mr. Regulatory
Mr Regulatory Short Intro
0:42
Mr. Regulatory
Is FDA Willfully Blind?
7:37
Mr. Regulatory
Why Should We Be Concerned About the Revolving Door At FDA?
7:01
Mr. Regulatory
Why Is Public Trust So Low?
10:52
Mr. Regulatory
Is FDA Being Unscientific?
8:46
Mr. Regulatory
What's The Harm Of Regulation?
9:28
Mr. Regulatory
How Do We Get Draconian Policies In The US?
9:27
Mr. Regulatory
David's Experience with Theranos
8:51
Mr. Regulatory
Shared Narratives and Incentives
13:33
Mr. Regulatory
RegAF 2021 Presentation: So You Want To Market a Home Use Device?
51:58
Mr. Regulatory
RegAF Short: Mr Regulatory Stories from FDA
2:18
Mr. Regulatory
RegAF Short: How Is FDA Doing? Still true?
3:07
Mr. Regulatory
RegAF Short: FDA Electrical Safety and EMC Considerations
3:56
Mr. Regulatory
Channel Updates: Vacation Edition
1:14
Mr. Regulatory
Short Update
0:17
Mr. Regulatory
Mr. Regulatory Live Stream
Mr. Regulatory
RegAF Short: More Bite Sized Videos Coming Soon
1:09
Mr. Regulatory
EP 26: Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation
31:13
Mr. Regulatory
EPISODE 25: Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
28:25
Mr. Regulatory
EPISODE 24: Requesting FDA Feedback on Combination Products
24:53
Mr. Regulatory
EPISODE 1: P200022 Simplify® Cervical Artificial Disc
15:03
Mr. Regulatory
EPISODE 23: De Novo Classification Process (Evaluation of Automatic Class III Designation)
29:33
Mr. Regulatory
EPISODE 22: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
33:00
Mr. Regulatory
EPISODE 21: Acceptance Review for De Novo Classification Requests
25:09
Mr. Regulatory
EPISODE 20: Refuse to Accept Policy for 510(k)s
48:43
Mr. Regulatory
EPISODE 19: Technical Considerations for Non-Clinical Assessment/Medical Devices Containing Nitinol
26:29
Mr. Regulatory
EPISODE 18: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
18:52
Mr. Regulatory
EPISODE 17: Nonbinding Feedback After Certain FDA Inspections of Device Establishments
18:45
Mr. Regulatory
EPISODE 16: Supplements for Approved PMA or HDE Submissions During COVID-19 Public Health Emergency
15:56
Mr. Regulatory
EPISODE 1: RegAF2020 - Remote Patient Monitoring: Is This a New Normal?
51:16
Mr. Regulatory
EPISODE 15: Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
26:38
Mr. Regulatory
EPISODE 14: Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
19:35
Mr. Regulatory
EPISODE 13: Recognition and Withdrawal of Voluntary Consensus Standards
26:51
Mr. Regulatory
EPISODE 12: Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
25:53
Mr. Regulatory
EPISODE 11: Multiple Function Device Products - Policy and Considerations
35:13
Mr. Regulatory
EPISODE 10: Enforcement Policy for Viral Transport Media During the COVID-19 Public Health Emergency
20:39
Mr. Regulatory
EPISODE 9: Providing Regulatory Submissions for Medical Devices in Electronic Format
16:27
Mr. Regulatory
EPISODE 8: Notifying CDRH of Permanent Discontinuance/Interruption in Device Manufacturing/COVID-19
14:55
Mr. Regulatory
EPISODE 7: Enforcement Policy for Face Masks & Respirators During COVID-19 Public Health Emergency
25:28
Mr. Regulatory
EPISODE 6: Statistical Considerations for Clinical Trials During COVID-19 Public Health Emergency
15:10
Mr. Regulatory
EPISODE 5: Unique Device Identification Compliance Dates
14:55
Mr. Regulatory
EPISODE 4: Review and Update of Device Establishment Inspection Processes and Standards
10:15
Mr. Regulatory
EPISODE 3: Effects of COVID-19 on Formal Mtgs./User Fee Applications for Medical Devices
13:50
Mr. Regulatory
EPISODE 2: Product Recalls, Including Removals and Corrections
26:27
Mr. Regulatory
EPISODE 1: Enforcement Policy for Non-Invasive Remote Monitoring/COVID-19
20:33
Mr. Regulatory
Welcome to the Mr. Regulatory "FDA Guidance Review" Video Series
1:46