21 CFR 820 - Risk Management - Looking for some guidance

[Achal]

Hi,

I am looking for some guidance on 21 CFR 820.

In Design validation- There is mention of risk analysis, Does that mean I have to follow ISO 14971 for risk management as there is no reference to this standard?

Thank You,
Achal

 

[William55401]

You are on the right track. FDA maintains a list of recognized consensus standards and 14971 (please do your own due diligence on the edition / version) is on the list.

Here's an URL of interest
Recognized Consensus Standards

 

[Watchcat]

Does that mean I have to follow ISO 14971 for risk management as there is no reference to this standard?

As far as FDA is concerned, you don't have to follow ISO 14971. However, if you don't, you are choosing to try to reinvent the wheel, with no guarantee that FDA will like your wheel. Since many experts collaborated to invent the ISO 14971 wheel, your chances of equaling that effort are pretty slim, even if you're a risk management rock star.

I myself would weigh this decision based in part on how likely FDA is to look at your wheel, much less kick the tires, and in part on whether you plan to market in other jurisdictions that might require/recognize ISO 14971.

 

[Ajit Basrur]

Hi,

I am looking for some guidance on 21 CFR 820.

In Design validation- There is mention of risk analysis, Does that mean I have to follow ISO 14971 for risk management as there is no reference to this standard?

Thank You,
Achal

You can refer to ISO - ISO/TR 24971:2020 - Medical devices — Guidance on the application of ISO 14971 as well for additional information.