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lotter on DSK11XQN23PROD with RULES1

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations subject discontinuation, subject complaints, device failures including unexpected software events if applicable and replacements, tabulations of data from all individual subject report forms and copies of such forms for each subject who died during a clinical investigation or who did not complete the investigation, results of statistical analyses of the results of the clinical investigations, contraindications, warnings, precautions, and other limiting statements relevant to the use of the device type, and any other appropriate information from the clinical investigations. Any investigation conducted under an IDE under part 812
of this chapter must be identified as such. Information on clinical investigations involving human subjects must include the following:
A For clinical investigations conducted in the United States, a statement with respect to each investigation that it either was conducted in compliance with the institutional review board regulations in part 56 of this chapter, or was not subject to the regulations under 56.104
or 56.105 of this chapter, and that it was conducted in compliance with the informed consent regulations in part 50
of this chapter; or if the investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance.
Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.
B For clinical investigations conducted in the United States, a statement that each investigation was conducted in compliance with part 812
of this chapter concerning sponsors of clinical investigations and clinical investigators, or if the investigation was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.
C For clinical investigations conducted outside the United States that are intended to support the De Novo request, the requirements under 812.28 of this chapter apply. If any such investigation was not conducted in accordance with good clinical practice GCP as described in 812.28a of this chapter, include either a waiver request in accordance with 812.28c of this chapter or a brief statement of the reason for not conducting the investigation in accordance with GCP
and a description of steps taken to
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ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation.
D A statement that each investigation has been completed per the protocol or a summary of any protocol deviations.
E A financial certification or disclosure statement or both as required by part 54 of this chapter.
F For a De Novo request that relies primarily on data from a single investigator at one investigation site, a justification showing that these data and other information are sufficient to reasonably demonstrate the safety and effectiveness of the device when subject to general controls or general and special controls, and to ensure that the results from a site are applicable to the intended population.
G A discussion of how the investigation data represent clinically significant results, pursuant to 860.7e.
16 Other information. i A
bibliography of all published reports not submitted under paragraph a15 of this section, whether adverse or supportive, known to or that should reasonably be known to the requester and that concern the safety or effectiveness of the device.
ii An identification, discussion, and analysis of any other data, information, or report relevant to an evaluation of the safety and effectiveness of the device known to or that should reasonably be known to the requester from any source, foreign or domestic, including information derived from investigations other than those in the request and from commercial marketing experience.
iii Copies of such published reports or unpublished information in the possession of or reasonably obtainable by the requester, if requested by FDA.
17 Samples. If requested by FDA, one or more samples of the device and its components. If it is impractical to submit a requested sample of the device, the requester must name the location at which FDA may examine and test one or more of the devices.
18 Labeling and advertisements.
Labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings must be supplied.
19 Other information. Such other information as is necessary to determine whether general controls or general and special controls provide reasonable
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assurance of safety and effectiveness of the device.
b Pertinent information in FDA files specifically referred to by a requester may be incorporated into a De Novo request by reference. Information submitted to FDA by a person other than the requester will not be considered part of a De Novo request unless such reference is authorized in writing by the person who submitted the information.
c If the requester believes that certain information required under paragraph a of this section to be in a De Novo request is not applicable to the device that is the subject of the De Novo request, and omits any such information from the De Novo request, the requester must submit a statement that specifies the omitted information and justifies the omission. The statement must be submitted as a separate section in the De Novo request and listed in the table of contents. If the justification for the omission is not accepted by FDA, FDA
will so notify the requester.
d The requester must update the pending De Novo request with new safety and effectiveness information learned about the device from ongoing or completed studies and investigations that may reasonably affect an evaluation of the safety or effectiveness of the device as such information becomes available.
860.230

Accepting a De Novo request.

a The acceptance of a De Novo request means that FDA has made a threshold determination that the De Novo request contains the information necessary to permit a substantive review. Within 15 days after a De Novo request is received by FDA, FDA will notify the requester whether the De Novo request has been accepted.
b If FDA does not find that any of the reasons in paragraph c1 of this section for refusing to accept the De Novo request apply or FDA fails to complete the acceptance review within 15 days, FDA will accept the De Novo request for review and will notify the requester. The notice will include the De Novo request reference number and the date FDA accepted the De Novo request. The date of acceptance is the date that an accepted De Novo request was received by FDA.
c1 FDA may refuse to accept a De Novo request if any of the following applies:
i The requester has an open or pending premarket submission or reclassification petition for the device;
ii The De Novo request is incomplete because it does not on its face contain all the information required
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