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Hi All,
Below is the excerpt of the FDA guidance regarding annual reports for Approved PMA. I appreciate your answer to my question below.
i. Unpublished reports of data from any clinical investigations or nonclinical
laboratory studies
involving the device or related devices and known to or that
reasonably should be known to the applicant.
- For item i, we are including to our annual report any clinical investigations or nonclinical laboratory studies involving our device and other related devices (competitors)
ii. Reports in the scientific literature
concerning the device and known to or that reasonably should be known to the applicant.
- For item ii, should we include the scientific literatures involving related devices (competitors)?.
Thank you.