- March 19, 2019
03:00 PM - 04:30 PM EDT
On Tuesday, March 19, 2019, the FDA will host a webinar to share information and answer questions regarding the implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The rule updates the standards for accepting clinical data from clinical investigations conducted inside and outside the United States to protect human participants, and to help ensure the quality and integrity of data obtained through such investigations.
The FDA issued this final rule on February 21, 2018, along with guidance providing clarification and recommendations to help stakeholders understand and comply with the updated requirements in the final rule. The final rule applies to all clinical investigations that enroll the first subject on or after February 21, 2019, and support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP), or humanitarian device exemptions (HDE).