Class III device and shelf life data requirements

[tehuff]

Hi experienced Covers - What are FDA's current expectations for shelf life data at time of submission for a Class III implantable device? What combination of accelerated aged and real-time data is necessary? Example: desired 2 year shelf life; can we submit 2 year accelerated aged data + 6 mos real-time (or more but <2 years) and still label a 2 year shelf life at commercial launch? What has been your recent experience? TIA!

 

[indubioush]

What type of submission are you talking about? IDE? PMA?

 

[tehuff]

Sorry, PMA.

 

[indubioush]

Have you already done a clinical study?

 

[tehuff]

Yes, clinical study data will be available at time of submission.

 

[indubioush]

I don't have recent experience, but I would aim for the 2 year shelf life and provide them all of your data. They could come back and tell you no, but it is worth trying. The important thing to focus on is that your real-time aging protocol is up to their standards.

 

[Junn1992]

I know for the EU you can always check with your NB or testing company, not sure for US

 

[planB]

What are FDA's current expectations for shelf life data at time of submission for a Class III implantable device?

Accelerated-aging data for your labelled shelf life is sufficient. Have a look into recognized consensus standard ISO 11607-1:2019, sections 8.3.3 and 8.3.4 - quote:

8.3.3 Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.
8.3.4 If accelerated aging is conducted, it shall begin within three months of real-time aging, unless an alternative rationale has been developed. Real-time aging shall be started prior to commercialization.

HTH,