FDA Advisory No. 2020-761 || FDA CLEARANCE OF RESPIRATORY THERAPY DEVICES PRIOR CUSTOMS RELEASE

In order to expedite customs release of Respiratory Therapy Devices to be used in treating COVID-19 patients, the following procedures shall be observed:

Importers of Respiratory Therapy Devices need only to present copies of their License to Operate prior customs release.

Also, foreign donations of Respiratory Therapy Devices to be used in treating COVID-19 patients need not require clearance from FDA prior customs release.

Said procedures shall be in effect until otherwise lifted.

For your guidance.

Attachment:-> FDA Advisory No.2020-761

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