Device Recalls & Vigilance - When to Report Complaints – Part 803 and Part 806

Why Should You Attend:

FDA has explicit complaint handling requirements and procedures. However due to inadequate compliant handling system/process many medical device firms face regulatory issues in both the European Union & the USA. Poor or inadequate compliant handling can be quite expensive resulting in poor customer relations, loss of sales. On top of that failure to report problems to regulatory agencies promptly results in costly regulatory action . FDA warning letters and recalls are posted on FDA’s website and published in trade magazines, newspapers available to firm’s competitors, and has even driven the firm’s stocks down. This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

Areas covered in this webinar:

• FDA’s Complaint Definition 820.3 (b).
• Complaint Documentation.
• Part 803 – Medical Device Reporting.
• Part 806 – Reports of Corrections & Removals.
• Warning letters and other FDA Remedies.
• Complaint Handling Pitfalls.