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FDA PRODUCT/ASSIGNMENT CODES (PAC)

Posted by: Nicole Thibodeau, 3 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

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
RE: MDCG 2023-4 and classification

Posted by: Richard Vincins, 6 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

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
RE: MDCG 2023-4 and classification

Posted by: Anne LeBlanc, 9 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

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
MDCG 2023-4 and classification

Posted by: Dragan Jovic, 15 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

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
RE: DMF Fee for Type II API DMF to be referenced in NDA submission

Posted by: , 21 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous For NDAs, no fee, only for ANDAs with CA needed!

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Unanswered posts

FDA PRODUCT/ASSIGNMENT CODES (PAC)

By: Nicole Thibodeau , 3 hours ago

Posted in: Regulatory Open Forum

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. ------------------------------ ...
Call for Authors: A Brand-New Device Fundamentals ...

By: Shawn Schmitt , yesterday

Posted in: Regulatory Open Forum

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 ...
SBOM

By: Shimon Vaknin , yesterday

Posted in: Regulatory Open Forum

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
eSTAR query on Guidance and Special Control Adhere ...

By: Rabel Talpur , yesterday

Posted in: Regulatory Open Forum

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 ...
DMF Fee for Type II API DMF to be referenced in NDA ...

By: Anonymous Member , yesterday

Posted in: Regulatory Open Forum

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 ...