The Food and Drug Administration (FDA) released an updated Guidance for FDA Staff for Sponsors, Contract Research Organizations (CROs) and Monitors on April 19, 2017 as part of the Bioresearch Monitoring (BIMO) program. The updated version contains revisions to Part III, section D, which provides additional instructions to FDA investigators related to www.ClinicalTrials.gov reporting and registration requirements that came into effect on January 18, 2017 in 42 CFR Part 11. The following highlight the main changes recommended by the FDA in the updated guidance:
- Form FDA 3674 is now recommended to accompany a 510(k) that refers to, relates to, or includes information on a clinical trial.
- Applicable clinical trials to be registered as defined by 42 CFR Part 11.
- We recommend checking www.ClinicalTrials.gov to determine requirements based on the date of study initiation.
- Pediatric postmarket surveillance of a device product that is not a clinical trial must be registered no later than 21 days after FDA approves the postmarket surveillance plan.
In addition to these changes, minor administrative corrections were made to the guidance manual.
What exactly is the purpose of the BIMO Guidance Manuals? These guidance documents provide the answer to the “test” for potential FDA inspections, whether it is for Clinical Investigators, Institutional Review Boards, Sponsors/CROs/Monitors, etc. These guidance manuals document in detail what FDA staff review during an inspection tailored to the type inspection being performed.
According to the BIMO Metrics released since 2007, the FDA performs over 1,000 audits each year and on average, 100-200 Sponsor/CRO/Monitor Organizations are included in those audits. In order to prepare for a FDA audit, understanding these guidance documents is important to successfully surviving without a 483 or warning letter from the FDA. However, of the 117 audits of Sponsor/CRO/Monitor Organizations in 2015, 31% resulted in “Voluntary Action Indicated” and 8% resulted in “Official Action Indicated”. As such, preparation is key to success and having a plan of action in case your organization does receive a 483 letter, is vital.
What tools do you find helpful for preparing for FDA Audits? What advice do you have to ensure compliance with FDA regulations?
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
