Premarket Notification Submission -- 510(k), Subpart E

ICR 199809-0910-001

OMB: 0910-0120

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5732
Migrated
ICR Details
0910-0120 199809-0910-001
Historical Active 199302-0910-008
HHS/FDA
Premarket Notification Submission -- 510(k), Subpart E
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 10/29/1998
Retrieve Notice of Action (NOA) 09/01/1998
This collection expired on 8/31/93 and was in use for five years without OMB approval. This is a clear violation of the Paperwork Reduction Act. FDA shall take careful steps to ensure that this an administrative error shall not occur with this collection in the future.
  Inventory as of this Action Requested Previously Approved
10/31/2001 10/31/2001
5,000 0 0
410,000 0 0
0 0 0

Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulation, 21 CFR 807.81, require a person/manufacturer who intends to market a medical device to submit a premarket notification submission to FDA at least 90 days before proposing to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use. Based on the informaton provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device, as defined in 21 CFR 807.92(a)(3).

None
None


No

1
IC Title Form No. Form Name
Premarket Notification Submission -- 510(k), Subpart E

  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 5,000 0 0 5,000 0 0
Annual Time Burden (Hours) 410,000 0 0 410,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
09/01/1998


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