New FDA Clinical Investigation Data Requirements in Effect

On February 21, 2019 the new rule allowing clinical data from clinical investigations from outside the United States (OUS) (21 CFR part 814) and new acceptance criteria in 21 CFR parts 807 and 812 Subpart B set forth last year went into effect. The new rule ensures the quality and integrity of clinical investigation data and the protection of study participants. Data from clinical investigations conducted outside the US that began on or after February 21, 2019 must comply with the new requirements. Good clinical practice (GCP) should be employed, which includes review and approval by an independent ethics committee (IEC) and informed consent from subjects. The new acceptance criteria added to 21 CFR parts 807 and 812 Subpart B also adds documentation requirements for applicants that have clinical investigation data generated within the United States.

The new rule requires that medical device applicants provide the FDA with information about how clinical investigations related to the device were conducted. The provisions under 21 CFR 812.28 apply. The information required for OUS clinical investigations includes;

  • Statement that the investigation was conducted in accordance with GCP (21 CFR 812.28(a)(1);
  • The names of the investigators and the names and addresses of the research facilities and sites where records relating to the investigation are maintained;
  • The investigator’s qualifications;
  • A description of the research facility;
  • A detailed summary of the protocol and results and, should FDA request, case records maintained by the investigator or additional background data such as hospital or other institutional records;
  • Either a statement that the device used in the investigation is identical to the device that is the subject of the submission, or a detailed description of the device used in the investigation and a comparison to the device that is the subject of the submission;
  • If the investigation is designed to support the safety and effectiveness of a device, a discussion demonstrating that the data constitute valid scientific evidence within the meaning of 21 C.F.R. § 860.7;
    The name and address of the Independent Ethics Committee (IEC) that reviewed the investigation;
  • A summary of the IEC’s decision to approve or modify and approve the investigation;
  • A description of how informed consent was obtained;
  • A description of any incentives provided to the subjects to participate;
  • A description of how the sponsor monitored the investigation; and
  • A description of how investigators were trained to comply with GCP and to conduct the investigation in accordance with the protocol.
If such information is not available, the sponsor can either;
  • provide a description of the methods used to ensure data quality, credible results, and that the rights and safety of subjects have been adequately protected or 
  • request a waiver in accordance with 21 CFR 812.28(c).
Waiver requests may be part of the pre-submission, an original IDE, a device marketing application, supplemental application, or an amendment to an IDE or device marketing application/submission. A waiver request should include at least one of the following;
  • An explanation as to why compliance with the requirement is unnecessary or cannot be achieved;
  • A description of alternate methods that were used to satisfy requirements;
  • Other information justifying a waiver.

Applicants with clinical investigation data from within the United States should provide a statement that the investigation was conducted with compliance with Protection of Human Subjects regulations in 21 CFR part 50, the Institutional Review Boards Regulations in 21 CFR part 56 and the Investigational Device Exemptions regulation in 21 CFR part 812 or a statement describing reasons for noncompliance.


Jasmin Hunter
Post date: March 18, 2019
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