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# New Device Human Subject Protection Rule Now in Effect
- URL: https://www.fdaweb.com/new-device-human-subject-protection-rule-now-in-effect/
- Published: 2019-02-21T12:00:00.000Z
- Updated: 2026-09-15T01:06:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143440

FDA is reminding stakeholders that 2/21 is the effective date for compliance with the [final rule](https://www.federalregister.gov/documents/2018/02/21/2018-03244/human-subject-protection-acceptance-of-data-from-clinical-investigations-for-medical-devices?utm%5Fcampaign=Acceptance%20of%20Data%20from%20Clinical%20Investigations%20Webinar&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=980A2A412C51B10FFA451B137897E9DD&elq=297bb5668ca94005b027f73a619fa7a8&elqaid=6823&elqat=1&elqCampaignId=5601) on *Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices*. The agency says the change will require that data submitted from clinical investigations outside the U.S. to support an IDE, 510(k), request for *de novo* classification, PMA, PDP, or HDE be from investigations conducted in accordance with good clinical practice, including obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee and obtaining and documenting freely given informed consent of subjects.

“The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects,” the preamble to the regulation says. “As part of this final rule, we are also amending the IDE, 510(k). and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.”  

To assist sponsors, FDA has launched a [new Web page](http://app.info.fda.gov/e/er?utm%5Fcampaign=Acceptance%20of%20Data%20from%20Clinical%20Investigations%20Webinar&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6584&elqTrackId=5CA4B46233E6768A649263424488CFED&elq=297bb5668ca94005b027f73a619fa7a8&elqaid=6823&elqat=1) to provide information on Good Clinical Practice along with instructions and information about what to include in applications to meet the final rule requirements. It also includes information on how to request a waiver.

Additionally, FDA has updated two existing guidance documents to reflect the new requirements: 

- [*Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff*](http://app.info.fda.gov/e/er?utm%5Fcampaign=Acceptance%20of%20Data%20from%20Clinical%20Investigations%20Webinar&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6583&elqTrackId=5E5490393D71CF2D4717FAE094C5E7C4&elq=297bb5668ca94005b027f73a619fa7a8&elqaid=6823&elqat=1)
- [*Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff*](http://app.info.fda.gov/e/er?utm%5Fcampaign=Acceptance%20of%20Data%20from%20Clinical%20Investigations%20Webinar&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=6582&elqTrackId=61A3D54764ABBBF6B62E1617F3DB6967&elq=297bb5668ca94005b027f73a619fa7a8&elqaid=6823&elqat=1)