3.5 Clinical/Regulatory
3.51 Clinical Update: Clinical updates include information on IDE/PMA studies, specifically studies that are listed on clinicaltrials.gov*
When sourcing information from clinicaltrials.gov, link to the verb and write clinicaltrials.gov at the end of the update in italics.
3.52 Regulatory: Regulatory updates refer to FDA approvals and clearances, regulatory approvals outside the US (CE Mark, etc.) and product recalls. This can also include information on when a company expects to receive regulatory clearance/approval.
For FDA regulatory milestones, link to the appropriate verb (i.e., approved/cleared, or received approval/clearance).
FDA approved devices are those that undergo the following regulatory pathways: PMA, HDA, BLA, NDA, IND, HDE.
FDA cleared devices are those that undergo a 510(k) pathway.
Human tissue and Class I devices are categorized as Exempt.
For devices with CE Mark certification, link to the verb such as received or issued.
For most other OUS regulatory approvals, link the verb approved or received approval.
If there are no clinical update, please include the phrase, "No recent clinical updates" in the Clinical Update article.