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August 17, 2020

Posted by Michael Hamrell in Uncategorized.
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The FDA has released their final guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff (August 2020)”.  This guidance finalizes FDA’s plans for civil monetary penalties for certain violations of the listing requirements related to the Clinicaltrials.gov database.  Since 2007 the FDA and Public Health Service have required a sponsor of a study to submit registration and results information to the publicly accessible database for ‘applicable clinical trials’.  This was codified in 42 CFR §11, finalized in 2017.

The new guidance provides details for how FDA intends to handle the implementation of the penalties for failures to follow the regulations regarding clincialtrials.gov.  The FDA has the oversight and enforcement authority under the regulations,  Generally, the Centers intend to identify violations of the FD&C Act’s requirements relating to the ClinicalTrials.gov data bank through evidence collected during inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO).

When a Center believes that a responsible party for an applicable clinical trial may have committed a prohibited act the Center generally intends to send the responsible party a Preliminary Notice of Noncompliance (Pre-Notice) Letter, which describes the potential violation and requests that the responsible party take any necessary actions to address the potential violation within 30 calendar days after receiving the letter.  After the Letter is sent, a sponsor has defined time periods (listed in the guidance) to respond by either correcting the violation or appealing.  The guidance further describes the appeal and review process and how FDA will handle the final adjudication of any violation.

The statutory maximum penalties under the FD&C Act for committing these prohibited acts are not more than $10,000 for all violations adjudicated in a single proceeding and, if a violation is not corrected within 30 days following notification of such violation provides for an additional civil money penalty of not more than $10,000 for each day that the violation continues after such period until the violation is corrected.


Medical Device Clinical Trials August 4, 2020

Posted by Michael Hamrell in Uncategorized.
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The International Organization for Standardization (ISO), a network of national standard bodies that develops voluntary standards, has recently released a new, revised version of their global clinical research standard; ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice.  The ISO 14155 has been updated to the third edition and released in July 2020.  The previous version was released in 2011.

ISO 14155 addresses GCP for medical device studies including the design, conduct, recording, and reporting of clinical investigations. This new edition strengthens the risk management requirements across all phases of the clinical investigation process, including pre- and post-market clinical investigations.   If you would like a copy of the new ISO standard, check out the ISO webpage.

Unlike ICH and FDA Guidance documents, ISO standards need to be purchased for use.