This new pathway is a considerable change for the medical device industry.
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
When it comes to adverse event reporting, the FDA does not grant exemptions.
Can your company prove its device has been manufactured in accordance with its DMR?
Audits are the cornerstone of a QMS.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.
The agency has issued its list of the most common inspectional observations for FY 2017.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
Overall, MDSAP will reduce the time and resources required for audits and inspections, and aid in international trade.
If your firm does not have an MDR procedure, FDA will find out.