We welcome the agency's desire to continue elevating the high standards of the IVD industry, but believe that FDA interpretation and policy play a role in the current situation. We have therefore recommended two actions we believe the Agency can and should take if it is to increase enforcement around RUO sales into clinical diagnostics labs:
- Allow a broader range of products to qualify as "components" under 21 CFR 820.3(c)
- Reconsider or narrow the "system review" policy
Our reasoning and additional detail is provided in our full comments.
I have to admit I have a bit of trepidation about making these recommendations, as I'm typically more comfortable explaining FDA's positions to industry. I do think industry is frequently too quick to criticize FDA, but it may still be the case that there is opportunity for improvement in our regulatory and policy approach.
Thanks to everyone who commented on earlier drafts of these comments. I look forward to seeing what comes next and sharing any additional comments.