To provide an understanding on the requirements of 21 CFR Part 821 (Medical Device Tracking Requirements), including the responsibilities related to manufacturers/importers and requirements for distributors or multiple distributors. This webinar also provides content of your SOPs with respect to 21 CFR Part 821and the relationship the regulation has with the Unique Device Identifier (UDI)
Course Objectives:
Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention, triggering to promptly identify distribution information and remove a device from the market. The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (FD & C Act), 21 USC 360i(e) were added in 1990 to the Safe Medical Devices Act (SMDA) and amended upon 1997 by The Food and Drug Administration Modernization Act (FDAMA). With this webinar you will understand:
• Which medical devices require tracking and why
• Who has discretion to order the tracking and when is this order issued
• Which are the specific requirements that apply to manufacturers, importers, distributers, final distributor and multiple distributors
• Your responsibilities if you go out of business, sell your business, or cease to distribute a tracked device
• The association with the unique device identifier (UDI)
• Time frames to meet for reporting
• Who are in the distribution network
The webinar will also provide examples of warning letters associated to 21 CFR 821 (Medical Device Tracking Requirements).
Course Outline:
The following topics will be addressed during this webinar:
• Background Information on Medical Device Tracking and Purpose
• Key Definitions
• When does a Device Need to Meet the Requirements of a Tracked Device as per FDA
• Interval the Medical Device Tracking is Required for and Who is Required to Track
• Failure to Comply
• Requirements if You Cease Distribution or Go Out of Business
• What is the Intent of the Regulation/ Who is Involved in the Distribution Network
• Manufacturer’s Responsibilities
• Exemptions and Variances to 21 CFR 821
• Distributor’s Requirements
• Records and Inspections
• Examples of Warning Letters on Medical Device Tracking
• References
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality and Regulatory Management
• Quality Assurance
• Regulatory Compliance
• Marketing
• Sales
• Distributors
• Importers
• Authorized Representatives
• Document Control
• Supplier Quality