OK, so I just realized you are talking pharma, not medical devices, so neither 21 CFR 820 or the IDE regulations apply The IND also exempts investigational drugs from pretty much the same types of requirements, but if the study is a postmarket study that is not being conducted under an IND, that's irrelevant. Hopefully a drug RA specialist can tell you whether or not there is something equivalent to complaint files under cGMP, and, if so, whether entities that maintain these files must register with FDA. That is, if the CRO is maintaining them. When you say "...and then houses the documents," I'm not entirely sure whether you are referring to the sponsor or the CRO.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 18-Nov-2019 00:28
From: NIKITA KATHPAL
Subject: CRO Registration with FDA for approved medical device
The product is approved for use not under an IDE currently.
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Best Regards,
Nikita Kathpal, MS
Regulatory Officer II, USA & Canada
Pharm-Olam International
450 N. Sam Houston Parkway, E. Suite 250
Houston, TX 77060
Email: nikita.kathpal@pharm-olam.com
Direct line: +1 713-559-7964
Main: +1 713-559-7900
Ext. 11164
Original Message:
Sent: 17-Nov-2019 01:59
From: Julie Omohundro
Subject: CRO Registration with FDA for approved medical device
Yes, but that's what the E in IDE is all about. Devices distributed for use under an IDE are exempted from virtually every device regulation except Parts 50, 52, 54, and 812, including registration, listing, and all of Part 820 except for design controls. See 21 CFR 812.1(a).
Don't get me started on the guidance.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 16-Nov-2019 16:05
From: Anne LeBlanc
Subject: CRO Registration with FDA for approved medical device
An establishment that maintains complaint files per 21 CFR 820.198 is required to register.
https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
Depending on your agreement, they may not fall in that category.
The guidance on clinical investigation monitoring may give some insight into types of CRO responsibilities.
https://www.fda.gov/media/116754/download
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 14-Nov-2019 14:12
From: NIKITA KATHPAL
Subject: CRO Registration with FDA for approved medical device
The CRO is only receiving safety reports and determining whether the event and reportable and sending the determination to the Pharma company to report and then house the documents. Does the CRO need to be registered with the FDA or are there any other responsibilities that the CRO needs to meet.
------------------------------
Best Regards,
Nikita Kathpal, MS
Regulatory Officer II, USA & Canada
Pharm-Olam International
450 N. Sam Houston Parkway, E. Suite 250
Houston, TX 77060
Email: nikita.kathpal@pharm-olam.com
Direct line: +1 713-559-7964
Main: +1 713-559-7900
Ext. 11164
------------------------------