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Page 2 OI PMA /PRC Technician Certification of Competency and Limitations ECCL Specific Training PART II: The person named in PART IA has received specific training, to meet the requirements of Section
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What is oipma?
OIPMA stands for Ownership and control information for post-market activities.
Who is required to file oipma?
Medical device manufacturers, importers, and device user facilities are required to file oipma.
How to fill out oipma?
Oipma can be filled out online through the FDA's electronic submission system.
What is the purpose of oipma?
The purpose of oipma is to provide the FDA with information on the ownership and control of medical device manufacturers and importers.
What information must be reported on oipma?
Information such as the name and address of the manufacturer, importer, or device user facility, as well as information on the owners and operators of the organization, must be reported on oipma.
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