The Essentials of Food and Drug Administration Medical Device Regulations:A Primer for Manufacturers and Suppliers - Registration, Medical Device Reporting, Corrections and Removals (Recalls)

This program will cover the remaining regulations excluding the QSR which was covered in Part 1. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This program will cover the remaining regulations excluding the QSR which was covered in Part 1.

Areas Covered in the seminar:

• This session will cover the responsibilities of the manufacturer for the regulations not covered in Part 1, Registration and Listing, Labeling, Medical Device Reports and Corrections and Removals (Recalls).
• What are the additional responsibilities of the Medical Device Manufacturer?
• New rules for Registration and Listing-paying the fees.
• What is Labeling-what about websites and videos?
• Do I really have to report adverse events in multiple countries?
• What field actions require reporting to the FDA?

Who Will Benefit:

This webinar is especially helpful for new startup companies that are entering the medical device field for the first time. It is also helpful for individuals that have not worked in the medical device field previously.

Personnel new to the field should take both Part 1 and Part 2 sessions.

Persons responsible for developing medical devices.

Persons responsible for quality systems, quality assurance and quality control.

Persons responsible for complaints.