My analytical chemistry instrumentation community is preparing to expand into regulated markets: pharma & biopharma, forensics, and clinical testing. We're definitely steering clear of anything close to patient data in the community, but internally there's concern about compliance with US Federal labeling requirements when it comes to medical devices. Most of our products are used in basic research and technical settings that don't need U.S. FDA regulation, but we do sell some versions of the same instruments that are labeled "For in vitro diagnostic use". The "dual-use" hardware and software are the same as "unlabeled" versions, so discussions of their maintenance and use are mostly the same; the difference lies in the extra certification of the diagnostic versions.
To comply with regulations, my company is starting to require that all materials appearing on our websites be reviewed before they are posted to ensure they are not making inappropriate claims about diagnosing disease - including all posts to social media, hence our community.
There's a possibility that they may ask us to send them every customer post, comment, reply, document, blog, etc. to them for review before it can go live. Review takes 3-10 days with their current staff.
Does anyone else work in a dual-use environment? Do you have any insights into how to maintain a lively community? It seems a waste of time to review all posts as if they concerned medical diagnosis when most discussion is about basic research and finding the part number of an obscure O-ring. Any tips on how we can convince our compliance people that we'll just add terms to our T&Cs, monitor posts like we normally do, and remove ones that are inappropriate?
Thanks. - Josh
APPENDIX: Use cases
- Not a regulation concern: A scientist in a research lab using the equipment to purify chemicals produced by a new chemical reaction wants to discuss how best to purify the products
- Possibly a labeling regulation concern: A pharmaceutical company quality control technician wishes to discuss in general terms the best way to quantify trace impurities in powdered pharmaceutical samples
- Definitely a regulation concern: A clinical researcher in a hospital wished to discuss best practices for validating a new experimental diagnostic method using the version of a device that is labeled "For in vitro diagnostic use"
- Concern???: The hospital technician running diagnostic tests is looking for best ways to change an O-ring on the instrument - a routine maintenance function unconnected with diagnosis
In regulated situations, the instrument may be labeled "For In Vitro Diagnostic Use", and in general lab situations it would be labeled "Research use Only". The only real difference between them is that the diagnostic instruments must be certified to pass certain tests.