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Press Release
FDA approves MedMira's new HIV rapid test
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Experienced Consultants Specializing in Regulatory Affairs:
510(k) Submission (Pre-Market Notification)
PMA (Pre-Market Approval)
IDE (Investigational Device Exemption)
GMP (Good Manufacturing & Quality Assurance)
Medical Marketing Services
United State Agent Services
21 CFR 807.40(b) requires a foreign establishment to designate a United States Agent to act as their official correspondent.
The Food and Drug Administration defines the role of an United States Agent as:
Assisting FDA in communications with the foreign establishment.
Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment.
Registering and updating the establishment and its products.
Maintaining an office address in the United States.
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