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Unapproved or Uncleared Devices

BayBiotech.NET

Legal export provisions become applicable only when a device has not been approved or cleared for domestic marketing. Except 21CFR 812.18, no regulations have been codified to establish how the export of unapproved devices must be managed.

An unapproved deivce must meet the following criteria in order to qualify the for legal export:

1. meet the foreign purchaser's specifications

2. not be in conflict with the importing country's laws

3. be labeled," intended for export only" on the outside of the shipping package

4. not be sold or offered for sale in domestic commerce

Reference: Fundamentals of US Regulatory Affairs, Sixth Edition (Regulatory Affairs Professional Society).

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