Specific guidance

It belongs to 21 CFR 822, which covers postmarket surveillance ordered under section 522. Specific guidance can address study design, sample size or reporting for a device type and adds to the general guidance on these studies.

Specific guidance means guidance that provides information regarding postmarket surveillance for specific types or categories of devices or specific postmarket surveillance issues. This type of guidance may be used to supplement general guidance and may address such topics as the type of surveillance approach that is appropriate for the device and the postmarket surveillance question, sample size, or specific reporting requirements.

21 CFR, 822.3