FDA Resources for Implementing Final Rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices

FDA Resources for Implementing Final Rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices

The U.S. Food and Drug Administration (FDA) is reminding stakeholders that today is the effective date for compliance with 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 last year, on February 21, 2018, along with guidance providing recommendations to help stakeholders understand and comply with 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 that 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). As part of implementation, the FDA is providing resources to help stakeholders comply with the rule.

Acceptance of Clinical Data Web Page

This new page provides information on Good Clinical Practice along with instructions and information about what to include in applications to meet the requirements of the final rule. The web page also includes information on how to request a waiver when applicable.

Guidance Documents

In addition to the guidance we issued last year on “Acceptance of Clinical Data to Support Medical Device Applications and Submissions--Frequently Asked Questions,” today we updated two existing guidance documents to reflect the requirements of the final rule:

• Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff

Webinar 

On Tuesday, March 19, 2019, the FDA will host a webinar for stakeholders who want to learn more about the implementation of this final rule. No registration is necessary.

Questions?

For questions please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 or DICE@fda.hhs.gov.