Simply stated, an inspection needs to add some value; otherwise, what’s the point?
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.
When it comes to compliance, the FDA does not grant special dispensation.
Device establishments must maintain records of acceptable suppliers.
If an activity is not documented, it did not happen.
The agency wants to modernize its regulatory processes and make them more efficient.
The Inspiris Resilia valve is intended for aortic valve replacement.
The agency has cleared expanded use of the DigniCap for solid tumor cancers beyond breast cancer.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.