Manufacturing changes in a cleared 510(k)

[GPSteve]

Hello,

I would lilke to know if it is necessary to submit a new 510(k) for a manufacturing process change from a machining process to an injection process. Specially regarding the biocompatibility issues. We have all the tests for the previous cleared one that enters in contact with some contaminants and the new one will not have contact with those contaminants. The product here is an interference screw made of PEEK.

Thanks in advance.

 

[Ed Panek]

Deciding When to Submit a 510(k) for a Change to an Existing Device

Guidance to enhance the predictability, consistency, and transparency of the “when to submit” decision-making process for 510(k)s.

www.fda.gov

This is something you should deliberate and document in your QMS. No one knows your product and changes more than you so if you have a documented reason why you didn't sub a new 510(k) you have a document to show the FDA.