FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products ('HCT/Ps')

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Get an Understanding of FDA’s Applicable Statutory and Regulatory Requirements on HCT/P Products

There are HCT/P products including combination products that are regulated by the Center for Devices and Radiological Health (CDRH) as medical devices and those that are regulated by the Center for Biologics Evaluation and Research (CBER). For industry to navigate the FDA’s regulatory system to obtain an approval or clearance for HCT/P products, it is imperative we understand the applicable statutory and regulatory requirements and address those requirements satisfactory to the FDA’s expectation.

This conference by expert speaker Dr. David Lim is intended to discuss laws and regulations governing human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). In particular, statutory and regulatory requirements applicable for HCT/P products including good tissue practices (GTPs) will be presented. Dr. Lim will discuss what firms should know about statutory and regulatory requirements to bring HCT/P products to the US market including GTPs, helping you better implement and execute regulatory pathways/options available to the product types. This conference will provide great opportunities to learn about statutory and regulatory requirements applicable for HCT/P products.

Session Highlights:

  • Applicable Laws and Regulations
  • Key Definitions
  • Jurisdictions under FDA’s CDRH and CBER
  • Criteria Determining Regulatory Status for HCT/P Products
  • Combination Products
  • Stem Cell-Based Products
  • Regulatory Options for Consideration
  • Good Tissue Practices (GTPs)
  • Common Misconception Leading to Costly Mistakes
  • Navigating Regulatory Pathways for HCT/P Products – Dos and Don’ts
  • FDA Enforcement Actions
  • PASS-IT Suggestions

Who Should Attend

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic


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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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