Medical Device Tracking Requirements

Why Should You Attend:

Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention, 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).

Learning Objectives:

• Understand the requirements of 21 CFR Part 821 (Medical Device Tracking Requirements), including responsibilities, if you are a manufacturer, importer, distributor or multiple distributor
• Content of your SOPs with respect to 21 CFR Part 821
• The relationship 21 CFR Part 821 has with the Unique Device Identifier (UDI)

Areas Covered in the 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

Who Will Benefit:

• Quality and Regulatory Management
• Quality Assurance
• Regulatory Compliance
• Marketing
• Sales
• Distributors
• Authorized Representatives
• Document Control
• Supplier Quality

Vanessa Lopez
Sr Quality Regulatory Consultant, Quality and Regulatory Consulting Services

Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.

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