Medical Device Reporting

ICR 202202-0910-015

OMB: 0910-0437

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0437 202202-0910-015
Received in OIRA 202107-0910-003
HHS/FDA CDRH
Medical Device Reporting
Revision of a currently approved collection   No
Regular 02/22/2022
  Requested Previously Approved
36 Months From Approved 08/31/2024
2,130,295 2,130,285
223,368 223,338
0 0

This ICR collects information from medical device manufacturers, importers, and user facilities that are required to submit electronic and paper medical device reports (MDRs) to the Food and Drug Administration (FDA) and to maintain records, and who may also seek exemption from these requirements. The information that is obtained from these reports will be used to evaluate risks associated with medical devices and enable FDA to take appropriate regulatory measures to protect the public health. Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems so the Agency can protect the public health under the FD&C Act.

US Code: 21 USC 360i(a)(b)(c) Name of Law: FFDCA
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  86 FR 33708 06/25/2021
87 FR 9057 02/17/2022
Yes

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,130,295 2,130,285 0 0 10 0
Annual Time Burden (Hours) 223,368 223,338 0 0 30 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We are revising the information collection to reflect newly established reporting requirements for reclassified biologic devices.

$0
No
    Yes
    Yes
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
02/22/2022


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