§ 822.30. May I request exemption from the requirement to conduct postmarket surveillance?
113 words·~1 min read·
/us/cfr/t21/s§ 822.30·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
You may request exemption from the requirement to conduct postmarket surveillance for your device or any specific model of that device at any time. You must comply with the requirements of this part unless and until we grant an exemption for your device. Your request for exemption must explain why you believe we should exempt the device or model from postmarket surveillance. You should demonstrate why the surveillance question does not apply to your device or does not need to be answered for the device for which you are requesting exemption.
Alternatively, you may provide information that answers the surveillance question for your device, with supporting documentation, to the address in § 822.8.
Connections1 cite this
Cited by 1 section
register
Citation graph
cites case law
§ 822.30
May I request exemption from the requirement to conduct postmarket surveillance?
Fed. Reg.×1
Cites 0Cited by 1 across 1 source