New Proposed Medical Device Reporting Guidelines

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

New Proposed Medical Device Reporting Guidelines

PostPosted by DCNGA » Sat Jul 13, 2013 11:53 am

Nothing has improved, only worsened. I expect no less these days.. ... 359130.htm

The fox is still guarding the hen house..

2.12 What are my responsibilities for investigating a voluntary report when the source of the report is unknown to me?
In this case, you must evaluate the complaint to determine whether it represents an MDR reportable event [21 CFR 820.198(a) and 803.18]. Your evaluation must include information in your possession or information you can obtain by contacting a user facility, importer or other initial reporter related to the adverse event [21 CFR 803.50]. Such information would include what is provided in the voluntary report, along with your knowledge of the device [21 CFR 803.18; see also 21 CFR 803.17, 803.50(b), and 820.198]. Your decision about whether or not the event is an MDR reportable event should be based on the findings of your evaluation.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
User avatar
Posts: 5367
Joined: Fri Jun 18, 2010 3:16 pm
Location: US

Return to FDA

Who is online

Users browsing this forum: No registered users and 0 guests