Medical Device Courses | wms7 | Mentions https://medicaldevicecourses.com/members/wms7/activity/mentions/ Activity feed mentioning wms7. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 456c7ebfa2ae9541770988fa026bd646 alexandrabuga replied to the topic "FDA Regulations of Medical Device-Drug" - https://medicaldevicecourses.com/activity/p/14666/ Wed, 15 May 2019 18:59:00 -0400 I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CDRH, CDER, and CBER. When looking at the additional OCP link @wms7 provided, I found that…   Read more»

]]> 097c33e2bf7e834046feb7ca28054b77 alexandrabuga replied to the topic FDA Regulations of Medical Device-Drug in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/5899/ Sat, 27 Jan 2018 20:16:09 -0500 I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CDRH, CDER, and CBER.

When looking at the additional OCP link @wms7 provided, I found that if OCP doesn’t have enough information to determine the PMOA of a product directly or cannot determine the…[Read more]

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