Safety Assurance Case

ICR 201404-0910-008

OMB: 0910-0766

Federal Form Document

Forms and Documents
IC Document Collections
ICR Details
0910-0766 201404-0910-008
Historical Active
HHS/FDA CDRH
Safety Assurance Case
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/23/2014
Retrieve Notice of Action (NOA) 04/10/2014
  Inventory as of this Action Requested Previously Approved
05/31/2017 36 Months From Approved
31 0 0
3,472 0 0
0 0 0

This ICR collects information from manufacturers of infusion pumps who intend to submit a safety assurance case (assurance case) with their premarket notification (510(k)) submission. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. However, FDA also believes an assurance case can be used to support claims that a device is safe for use. An assurance case is a systematic method of documenting a claim through a series of structured arguments, supported by a body of evidence that provides a compelling, comprehensible and valid case that the claim is true. Manufacturers submitting a 510(k) for modifications to a legally marketed infusion pump for which no assurance case exists, should develop and submit an assurance case for their infusion pump.

US Code: 21 USC 510 Name of Law: null
  
None

Not associated with rulemaking

  78 FR 16676 03/18/2013
79 FR 19616 04/09/2014
No

1
IC Title Form No. Form Name
Assurance Case Report (guidance section 6)

  Total Approved 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 31 0 0 31 0 0
Annual Time Burden (Hours) 3,472 0 0 3,472 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection.

$0
No
No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 [email protected]

  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.
04/10/2014


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