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In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions.

The public media has been reporting the fraud and abuse of narcotic dispensed for pain.

The training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.

All medical device manufacturers are required to comply with the complaint handling requirements and medical device reporting (MDR) pursuant to the applicable statutes and regulations.

DEA OFFICE OF DIVERSION CONTROL – familiarize the participant with the authority given to DEA when enforcing federal laws and regulations pertaining to controlled substances.

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.