Communication between FDA and Notified Body

[tll120]

Hi All,

If a company recently had its ISO 13485 decertified by its Notified Body, does the Notified body inform the FDA? Also, would this information preclude the FDA from reviewing new 510(k)s from this company?

Thank you!
TLL120

 

[planB]

Answer to your questions: NO

FDA does not recognize ISO 13485 and has only started a pilot programme in 2012 to consider ISO 13485 quality audit reports:

http ://www.fda .gov/ MedicalDevices/ DeviceRegulationandGuidance /GuidanceDocuments/ ucm212795.htm - DEAD LINK REMOVED.

HTH,

Gerhard

 

[tll120]

Thank you, Gerhard! What about if the company lost its CE Certification as well?

 

[planB]

Products get CE marked, not companies. CE marking is a European concept, so theoretically the company could still get a 510(k) submission approved.

But I seriously doubt that a company having such gross deficiencies with its NB and its 13485 quality system would be able to pass FDA scrutiny ...

HTH,

Gerhard

 

[somashekar]

Thank you, Gerhard! What about if the company lost its CE Certification as well?

The US 510k and the EU CE mark are mutually exclusive.
While the 510k is between you and FDA, the CE mark is between you and the NB, not the EU. There is every possibility that you can get your CE mark with an other NB.
The ISO from the NB is perhaps the ENISO 13485:2012, and not the ISO13485:2003., which is the international standard. However, be it ENISO or the ISO., FDA is not keen on that, and what matters to FDA is the FDA inspection, that can be scheduled by them at you within a short notice.

 

[ThasYuwa]

Please note that if the said company intends to manufacture and sell medical devices in jurisdictions other those covered by CE mark (for the specific product), the company should seriously consider reviewing actions (or lack there of) that resulted in the NB revoking the certification. These actions (e.g. failure to amend previously noted issues) will have negative impact on the company's ability to defend that its QSR compliance is satisfactory. The company implicitly makes this claim every time the company ships a product in the US.
I hope this helps.