Human Subject Protection; Acceptance of data from clinical studies for medical devices

ICR 201304-0910-008

OMB: 0910-0741

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-04-22
IC Document Collections
IC ID
Document
Title
Status
206693
New
ICR Details
0910-0741 201304-0910-008
Historical Inactive
HHS/FDA 19298
Human Subject Protection; Acceptance of data from clinical studies for medical devices
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 05/28/2013
Retrieve Notice of Action (NOA) 04/25/2013
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type. For data from clinical studies conducted inside the United States, we propose to require statements in 510(k) submissions and IDE applications that are similar to those currently required for PMA applications, to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. The proposed rule would require additional maintenance, retention, and submission of documents indicating (1) clinical studies conducted outside the United States and used to support IDE or device marketing applications or submissions are conducted in accordance with GCP, and (2) availability of data for FDA inspection, if deemed necessary. The information in this section (and in section #1) allows reviewers to assess the appropriateness and adequacy of the clinical trial design, data collection plans, and protect human subjects participating in medical device trials.

US Code: 21 USC 360j Name of Law: FD&C Act
  
None

0910-AG48 Proposed rulemaking 78 FR 12664 02/25/2013

No

1
IC Title Form No. Form Name
Reporting and Recordkeeping

Yes
Miscellaneous Actions
No
This is a new information collection.

$83,130
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
04/25/2013


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