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Part 812: Investigational Device Exemptions
Subpart A: General Provisions
21 CFR 812.2 - Applicability.
21 CFR 812.2(b) - (b) Abbreviated requirements. The following categories of investigations are considered to have ...
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21 CFR 812.2(c) - (c) Exempted investigations
21 CFR 812.2(c) - (c) Exempted investigations
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21 CFR 812.2(c)(3) - (3) A diagnostic device, if the sponsor complies with applicable requirements in § 809.10(c) and ...
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21 CFR 812.2(c)(7) - (7) A custom device as defined in § 812.3(b), unless the device is being used to determine safety...
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