For this week’s journey, Dr. D will attempt to provide a simplified approach for complying with 21 CFR, Part 820.50. Simply stated; “there is no such thing as minimum compliance and no such thing as maximum compliance; there is just compliance.”
Guess what happens if an offending device establishment is awarded with a number of Form 483 observations? If your answer begins with the word “warning” and ends with the word “letter” a.k.a., “warning letter” then you would be correct.
Unannounced audits are now a reality. It is imperative that you work closely with your notified bodies to ensure the transition to unannounced audits is a smooth one.
There are few things in life more frustrating than sitting across from FDA, during an inspection, and not being properly prepared with documented evidence of compliance. If the DHRs are not being properly completed or maintained, rest-assured, the investigator will cite the issue as a Form 483 observation.
Process Validation should be considered one of the basic tenants associated with the manufacturing of finished medical devices that are safe and effective in their intended use. However, what happens when a device establishment fails to implement an effective program for process validation?
If an establishment is manufacturing finished medical devices that are sterile, there should never be any excuses for not properly maintaining and monitoring the cleanroom or CER.
Put significant effort into the design and development planning phase. It really is the road map for a successful design and development process.
Device manufacturers should actually be listening when a customer calls with a complaint. Although being on the receiving end of a complaint is never pleasant, your customers are trying to tell you something.
Don’t be that organization that fails to file MDRs. FDA takes the need to report adverse events very seriously, so failing to file MDRs is a mortal sin in the eyes of FDA.
If clinicians performing clinical trials are categorized as Totally Restricted Investigators by FDA, then the clinical work is a wasted effort. Ensure that an appropriate level of due diligence is pursued prior to partnering with the clinicians selected to execute the clinical investigation.
