Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
There is no such thing as minimum or maximum compliance—there is just compliance.
As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
How can an establishment refuse to give requested information to FDA or fail to obtain product approval or clearance from the FDA? The winner of this week’s prized FDA Warning Letter “failed or refused” to furnish material or information requested by FDA.
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
FDA has given device establishments a gift in regard to the vagueness of the RI requirement. It is up to each device establishment to decide how much RI is required. However, at the end of the day the approach for RI must be defendable during an agency inspection, and when in doubt, the approach to RI should be risk-based.
Device History Records are not optional. So do not be that Chief Jailable Officer that has to sit across from that FDA investigator without the documented evidence of compliance needed to defend your establishment’s QMS (or lack of it).