Hardware Podcasts

Regulatory Tips & Pointers from a Former FDA Reviewer

Global Medical Device Podcast · 17 May 2021 · 47m · Episode 205

What this episode covers

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.

Most relevant to

established companies

Topics

Mentioned

Companies
Acknowledge Regulatory Strategies, Green Light Guru, FDA
Also
Regulatory Alliance for Medical Devices, Mr. Regulatory Guidance Digest

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 35m

    079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young

    Rumi Young, Director of Regulatory Policy at Becton Dickinson (BD), explains how the FDA reviews combination products, drawing on her previous tenure as Acting Assistant Director in CDRH’s Division of Drug Delivery. She details the inter-center consult process for products like auto-injectors and smart connected devices, highlighting the manual nature of current submissions and the critical need for clear device identification in NDAs and BLAs. Young discusses the role of industry in shaping policy, advocating for updated Essential Performance Requirements (EPRs) and international harmonization through IMDRF to address the gap between evolving technologies and outdated guidances.

    Connected products & IoTCertification & compliance
    8 chapters

  • Let's Combinate · 34m

    172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

    Doug Mead, founder of CP Pathways and Rhizome AI, explains how his company uses AI to search the FDA's Drugs@FDA database, enabling faster regulatory intelligence for combination products. He details the transition from manual Google searches to a specialized tool that handles OCR and semantic search to interpret review memos, human factors data, and Type C meeting minutes. Mead highlights the value of understanding FDA precedents for products like auto-injectors and on-body injectors, while noting limitations such as redacted data and unpublished supplement reviews.

    Connected products & IoTCertification & compliance
    7 chapters

  • Let's Combinate · 45m

    253 - FDA Is Making Big Changes to Its Inspection Approach

    Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific generalist model under the new Office of Investigations and Inspections (OII). He details the operational differences between routine inspections under Section 704 and undercover investigations under Section 702, emphasizing that investigators prioritize human subject safety over minor regulatory technicalities. Pittman advises industry to focus on the FDA’s Investigations Operations Manual (IOM) and specific compliance programs rather than cosmetic facility improvements, noting that the end of QSIT has shifted focus to broader process evaluation.

    Certification & complianceQuality & yield
    11 chapters

  • Let's Combinate · 31m

    206 - Will AI Decide Your Next Drug/Device Approval?

    Dominick Romano, founder of Drainpipe.io, explains how AI can be regulated in pharma and medtech by applying ICH guidelines and process validation to AI systems. He argues that pharmaceuticals are uniquely suited for AI because both deal with 'combinatorial problem sets' involving infinite inputs and outputs, requiring rigorous validation to prevent hallucinations in regulatory dossiers. Romano details how AI can accelerate dossier preparation by reducing millions of working hours in data acquisition and how regulators might use AI agents to speed up review processes, provided the technology is proven safe and accurate by the companies themselves.

    AI & machine learningCertification & compliance
    8 chapters

  • Let's Combinate · 1h 13m

    010 - "Don't Make Assumptions" with David Simoens

    David Simoens, COO of cGMP Consulting Group, explains how a risk-based approach can streamline commissioning, qualification, and validation (C&Q) in pharmaceutical manufacturing. He details the transition from traditional, repetitive testing to leveraging data from Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) through rigorous User Requirement Specifications (URS) and risk assessments. Simoens highlights common pitfalls, such as poorly written 70-page URS documents and inadequate debugging at the vendor site, which lead to significant project delays and cost overruns. He emphasizes the importance of using tools like FMEA and ISPE guidelines to identify critical aspects early, ensuring that testing is performed once and leveraged through to Performance Qualification (PQ).

    Manufacturing partners & offshoringQuality & yield
    9 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.