You must have established procedures for complaint management and MDRs.
These violators have caused serious injury or death to patients. Here we focus on AM2PAT’s former president, Dushyant Mahendrabhai Patel.
What’s up with the trend in Class I initiated recalls?
Some companies just don’t get it. If a device has been cleared or approved for a specific indication, it can only be advertised for that specific indication.
Take a quick trip to the FDA’s warning letter page and you’ll see the potential danger that novelty lenses pose.
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
Facilitating a RI department can quickly become an expensive proposition. Adding a vision system, mechanical inspection tools, a reasonably-sized surface plate, and hiring/training competent mechanical inspectors is not cheap. However, device establishments can mitigate some of the costs by implementing some pretty basic inspection concepts.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
A quick review of the violations in 2014 Warning Letters shows that FDA inspectors are scrutinizing multiple areas of operation, from production to receipt of supplies to management responsibilities to CAPA systems.