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Old 11-03-2017, 07:30 AM   #3
stevencwood
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Join Date: Oct 2017
Location: Los Angeles, California
Posts: 52
Quote:
Originally Posted by mlesemann View Post
I like it - it definitely makes me want to read more. And I think the level of technicality is about right.

My only criticism is that the FDA does not do its own investigations - it only reviews investigations that labs do. So replace it with a different agency - coroner? local police? FBI? Take your pick.
Thanks for checking it out. How does the quick dialogue work for you? I thought the same thing about the FDA and actually emailed their Medical Device Complaints Department. They responded back saying "The FDA does not get involved in legal matters." My original plan was to have these guys be FDA attorneys, which do exist, but do not serve whistle-blowers.

As far as investigations, they will do it if they receive "regulatory misconduct" reports. The following excerpt is taken from HERE


Quote:
If contact information is provided, CDRH (Center for Devices and Radiological Health) sends an acknowledgement letter to the submitter which includes an FDA-assigned identification number for the allegation report. This number is used in all follow-up communication to ensure that the report information is filed together.

CDRH assesses the allegation and determines the potential risk to patients, and CDRH will investigate further if warranted. After our assessment, we take appropriate action, which could include:

Regulatory actions such as sending a warning letter to the medical device firm, conducting an inspection of the manufacturing facility, or requesting a device recall.

Contacting the individual, firm or medical device manufacturer for additional information.

Monitoring the allegation using additional sources of reported information (e.g. medical device reports (MDRs), new complaints, inspection reports) to determine any action needed.
To avoid a potential bore, I skipped ahead to when the whistle-blower retained a firm. These guys specialize in medical device fraud (something I didn't know existed), which explains why they're so familiar with what should have happened prior to them getting a case file.

My only issue is finding out how this court case works. The firm will serve the company (New Life), and the case will be for manslaughter. The primary person on trial is the head of engineering. It will eventually come out that whatever was inside Robert Chavez's body, was able to be remotely shut down. This bit of functionality was left out when submitting he device to the FDA for approval.

Last edited by stevencwood; 11-03-2017 at 07:37 AM.
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