Hello, I was wondering if someone could let me know what the Product/Assignment (PAC) Code 82R801 as part of the OMDRHO/Division 1-East FY 24 work plan description is. I can't seem to find it anywhere. read more
Hello Dragan, I can second what Anne said, the software can remain as Class I in reference to the guidance documents you are citing. Though keep in mind, internally your documentation, the intended purpose read more
Hi Dragan You were right in the first place. Devices and accessories are each classified separately. It's normal to have class I devices and class II devices working together. If you had another read more
Hi community! I have a question here. If there is software for predicting fertility status based on certain parameters, according to MDCG 2019-11 that software should be classified as Class I. However, read more
This message was posted by a user wishing to remain anonymous For NDAs, no fee, only for ANDAs with CA needed!
View this profile on Instagram RAPS (@regulatoryprofessionals) โข Instagram photos and videos
RAPS (@regulatoryprofessionals) โข Instagram photos and videos
Hello, I was wondering if someone could let me know what the Product/Assignment (PAC) Code 82R801 as part of the OMDRHO/Division 1-East FY 24 work plan description is. I can't seem to find it anywhere. Thank you in advance. ------------------------------ ...
RAPS is recruiting experienced regulatory professionals with a knack for wordsmithing for a rewrite of its landmark book on the regulation of medical devices. The brand-new F undamentals of Medical Device Regulations: A Global Perspective ...
Hi Everyone, A short question (I hope): Where do you document the Software Bill of Material (SBOM) in the submission? I mean, in the SDD, Off-The-Shelf software report, or separately. Thanks! Shimon
Dear Raps Community, I am writing regarding query on the eSTAR section that refered in Device Description, Labeling, Reprocessing, sterility ,Shelf-Life and in performance Testing. as FDA requirement for below mentioned section is unclear. Our product ...
This message was posted by a user wishing to remain anonymous Dear all, <o:p></o:p> <o:p> </o:p> I have a question about DMF fee for Type II API DMF to be referenced in NDA submission.<o:p></o:p> <o:p> </o:p> To my knowledge, DMF fee ...
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
JoinMy RAPS DashboardLearn More
About UsTerms of UsePrivacy Policy