# Regulatory Tips & Pointers from a Former FDA Reviewer

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-05-17
- Length: 47m
- Episode: 205
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer
- Listen: https://podcast.greenlight.guru/episode/regulatory-tips-pointers-from-a-former-fda-reviewer

## Summary

Allison Komiyama, former FDA reviewer and owner of Acknowledge Regulatory Strategies, shares insights on the challenges facing the agency as veteran reviewers leave and new, remote staff struggle with mentorship. She explains how industry can improve review speeds by proactively supporting reviewers, such as by incorporating guidance documents into submissions and engaging in collaborative dialogue rather than relying solely on written correspondence. Komiyama also discusses the nuances of biocompatibility testing, noting that rigid checklists often lead to unnecessary animal testing and that reviewers should focus on risk-based interpretations of regulations.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=0) Introduction and Guest Background
- [6:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=408) Challenges for New FDA Reviewers
- [9:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=597) Writing Deficiencies and Managing Consults
- [13:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=780) Guidance Documents and Reviewer Knowledge Gaps
- [18:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=1105) Interpreting Regulations and the Spirit of the Law
- [25:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=1529) Biocompatibility and Master Files
- [33:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=2031) Collaboration and Communication with FDA
- [41:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer#t=2470) Conclusion and Resources

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

established companies

## Mentioned

- Acknowledge Regulatory Strategies (company)
- Green Light Guru (company)
- FDA (company)
- Regulatory Alliance for Medical Devices (other)
- Mr. Regulatory Guidance Digest (other)

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- [172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead](https://hardwarepodcasts.com/podcast/lets-combinate/2025-01-22-172-regulatory-ai-innovations-drugs-fda-database-regulatory-intelligence-strateg) (Let's Combinate)
- [253 - FDA Is Making Big Changes to Its Inspection Approach](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-07-253-fda-is-making-big-changes-to-its-inspection-approach) (Let's Combinate)
- [206 - Will AI Decide Your Next Drug/Device Approval?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-17-206-will-ai-decide-your-next-drug-device-approval) (Let's Combinate)
- [010 - "Don't Make Assumptions" with David Simoens](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-08-010-dont-make-assumptions-with-david-simoens) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-17-regulatory-tips-pointers-from-a-former-fda-reviewer. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.