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Not at all. The FDA allows preapproval display under 21 CFR 812.7. It is well understood to advance technology and acquire much needed peer input that unapproved devices will be shown and displayed. Clinical trials are the foundation to approval.I never said or implied the X-Porte device should not be out on road or tradeshow or facility display and clinical trial. Fujifilm Somosite's RA/QA Compliance department is responsible to ensure their activities are in compliance with the pre approval requirements and guidelines stipulated by the FDA.
Not at all. The FDA allows preapproval display under 21 CFR 812.7. It is well understood to advance technology and acquire much needed peer input that unapproved devices will be shown and displayed. Clinical trials are the foundation to approval.
I never said or implied the X-Porte device should not be out on road or tradeshow or facility display and clinical trial. Fujifilm Somosite's RA/QA Compliance department is responsible to ensure their activities are in compliance with the pre approval requirements and guidelines stipulated by the FDA.
