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Under 21 CFR 807.85 Exemption from premarket notification. It says:
(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:
(1) The device was in commercial distribution before May 28, 1976; or
(2) A premarket notification submission was filed by another person.
My question is: why it says "under his own name"? If it is under distributor's name, then the distributor should be the manufacturer according to the manufacturer's definition by FDA. Then this distributor shall have its own premarket notification, however, the section (b)(2) says if "A premarket notification submission was filed by another person." then premarket notification is exempted.
Looks like conflict. Can someone give some explanation?
(b) A distributor who places a device into commercial distribution for the first time under his own name and a repackager who places his own name on a device and does not change any other labeling or otherwise affect the device shall be exempted from the premarket notification requirements of this subpart if:
(1) The device was in commercial distribution before May 28, 1976; or
(2) A premarket notification submission was filed by another person.
My question is: why it says "under his own name"? If it is under distributor's name, then the distributor should be the manufacturer according to the manufacturer's definition by FDA. Then this distributor shall have its own premarket notification, however, the section (b)(2) says if "A premarket notification submission was filed by another person." then premarket notification is exempted.
Looks like conflict. Can someone give some explanation?
Good!!!