Understanding FDA Requirements to Manufacture & Market Medical Devices in the USA (from QMSR and beyond)

Understanding FDA Requirements to Manufacture & Market Medical Devices in the USA (from QMSR and beyond)

Course Duration: 3 Days

This three-day seminar addresses elements of the FDA’s requirements for manufacturing medical devices. The FDA has amended 21 CFR 820 to utilize the Quality Management System Regulation (QMSR) requirements of ISO 13485 in order to align more closely with international standards for medical devices. This course aligns regulatory understanding of the framework for the USA with that used by other global regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices to patients.

In addition, there are FDA requirements beyond the QMSR that are perhaps not as well understood. This course will therefore clarify these areas to aid the student to become familiar with these requirements in a less formidable or less intimidating environment than a typical regulatory atmosphere.

Learning Objectives

· Explore the specifics of 21 CFR 820, ISO 13485, and further requirements of Title 21 of the Code of Federal Regulations for medical device manufacturing.

· Provide a hands-on approach to setting up and/or assessing QMS and other processes to ensure compliance to medical device regulations in the US.

· Provide the competencies needed to introduce new processes (or changes to those processes) for the manufacture of medical devices with the confidence of meeting regulatory needs.

Course Outline

  • Chapter 1: 21 CFR 820 (The new QMSR)
  • 21 CFR 820 still goes beyond ISO 13485
  • The new scope (820.1)
  • Definitions within 820.3 (differences from ISO 13485)
  • Breakout Exercise 1: Identify 21 CFR 820 Changes vs. What Isn’t Changing (emphasis on differences)
  • 820.10: Requirements for a QMS – differences between 21 CFR 820 & ISO 13485 by paragraph/clause
  • 820.15: Clarification of concepts from ISO 13485 and how they are defined differently
  • Breakout Exercise 2: Identify References to Regulatory Requirements from both 21 CFR 820 and ISO 13485
  • Breakout Exercise 3: Identify the Differences 21 CFR 820 will Require with Utilization of ISO 13485
  • Chapter 2: 21 CFR 820 Subpart B – Supplemental Provisions
  • Record Control fundamentals in 820.35
  • Complaints and Servicing [sub para (a) & (b)]
  • UDI and Confidentiality [sub para (c) & (d)]
  • Breakout Exercise 4: Identify the Regulatory Requirements of Controlling Records
  • Device Labeling and Packaging Controls in 820.45
  • Examination prior to and eventual release [sub-para (a) & (b)]
  • Set-up Packaging and Labeling processes [sub-para (c)]
  • Breakout Exercise 5: Define Labeling and Packaging Controls
  • Chapter 3: Introduction to ISO 13485
  • Introduction, Purpose, Patient Safety & Quality
  • Key definitions of ISO 13485 and 21 CFR 820
  • Breakout Exercise 6: Define the Purpose, Scope and Differences between 21 CFR 820 & ISO 13485
  • Chapter 4: ISO 13485 Requirements
  • Clause 4: Quality Management System Requirements
  • Clause 5: Management Responsibility
  • Breakout Exercise 7: ID Requirement Relationships Based on Audit Scenarios for Clauses 4 & 5
  • Clause 6: Resource Management
  • Clause 7: Product Realization
  • Breakout Exercise 8: ID Requirement Relationships Based on Audit Scenarios for Clauses 6 & 7
  • Clause 8: Measurement, Analysis & Improvement
  • Breakout Exercise 9: ID Requirement Relationships Based on Audit Scenarios for Clause 8
  • Seminar Agenda (cont’d)
  • Chapter 5: Beyond pt 820 – Getting Started
  • Pt 1: General Enforcement Regulations
  • Pt 10: Administrative Practices and Procedures
  • Pt 2: General Administrative Rulings & Decisions
  • Pt 3: Product Jurisdiction
  • Pt 5: Organization
  • Pt 7: Enforcement Policy
  • Pt 19: Standard of Conduct & Conflicts of Interest
  • Breakout Exercise 10: Utilizing Each Concept (1)
  • Chapter 6: Beyond pt 820 – Manufacture & Sell
  • Pt 807: Establishment Registration & Device Listing
  • Pt 808: Exemptions (from federal preemption of state and local medical device requirements)
  • Pt 812: Investigational Device Exemptions (IDE)
  • Pt 814: Premarket Approval (PMA)
  • Pt 860: Medical Device Classification
  • Pt 801: Medical Device Labeling
  • Pt 830: UDI (Unique Device ID) Requirements
  • Pt 1150: User Fees
  • Pt 1401: Public Availability of Information
  • Breakout Exercise 11: Utilizing Each Concept (2)
  • Seminar Agenda (cont’d)
  • Chapter 7: Beyond pt 820 – Importance of Traceability
  • Pt 11: Electronic Records; Electronic Signatures
  • Pt 821: Medical Device Tracking Requirements
  • Pt 803: Medical Device Reporting
  • Pt 800: Device Detention
  • Pt 806: Medical Devices; Reports of Corrections & Removals
  • Pt 810: Medical Device Recall Authority
  • Pt 822: Post-Market Surveillance
  • Breakout Exercise 12: Utilizing Each Concept (3)
  • Chapter 8: Beyond pt 820 – Others Less Used pts
  • Pt 4: Regulation of Combination Products
  • Pt 1271: Human Cell, & Cellular & Tissue Based Products
  • Pt 861: Performance Standards Development (typically for Class II & Class III devices)
  • Pt 1402: Mandatory Declassification Review
  • Pts 862-1400: Specific Requirements by Device Type
  • Breakout Exercise 13: Utilizing Each Concept (4)
  • Appendix: Checklist of ALL “21 CFR Parts” (ref https://www.ecfr.gov/current/title-21)

Who Should Attend

Those who have responsibility for having regulatory knowledge necessary for manufacturing new and/or legacy products into the USA medical device market would benefit from this seminar. This includes: Top Management, Quality/Regulatory managers, Ops managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.

Course Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.

Pre-Requisite

No prior knowledge is necessary. However, a mix of students with knowledge of regulatory requirements and/or basic Quality Management System concepts is preferred.

Upcoming Training

Provide this course Onsite
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For Implementation Support

Understanding FDA Requirements to Manufacture & Market Medical Devices in the USA (from QMSR and beyond) Program is available in multiple locations globally, including the USA, Canada, Mexico, India, Europe, Thailand, Singapore, Middle East and China.

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