Hello Anon,
In answer to your question:
1. Typically the engineering drawings, diagrams, or technical information related to the product is in Module 1 concerning the Device Description. Module 2 and 3 also contain device description, but I have typically "shortened" this information as all of the technical information would be contained in Module 1. In some circumstances, if the information concerning engineering drawings and such are not yet finalised during Module 1, then these could be submitted as part of Module 2 or 3. Just note you might get some objectionable questions on the Module if not submitting substantial information already as part of Module 1.
2. Yes, the manufacturing processes, work instructions, testing procedures, inspections, etc., need to be provided in Module 3. These do need to be detailed and show exactly how the device is manufactured, because this will be verified during the Pre-Approval Inspection (PAI). As example, remember having to submit Annual Report or even Supplements because we changed a test method.
There information is on the FDA website:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-approval-application-modular-review or
https://www.fda.gov/media/83408/download may seek expert advice on the actual content of a submission.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 19-Aug-2022 22:40
From: Anonymous Member
Subject: Modular PMA Manufacturing Module
This message was posted by a user wishing to remain anonymous
Can anyone guide me if:
- FDA requires the sponsor to submit all the engineering drawings for the finish goods, sub-assemblies and components as a part of the Manufacturing Module of the PMA?
- FDA requires the sponsor to submit all Manufacturing Process/Work Instructions (WI) for all the processes as a part of the Manufacturing Module of the PMA?
If not, can you share the regulation or FDA guidance which provides additional information regarding this?