Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

ICR 201804-0910-001

OMB: 0910-0705

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-05-21
IC Document Collections
IC ID
Document
Title
Status
215616 Modified
197892 Modified
ICR Details
0910-0705 201804-0910-001
Active 201501-0910-006
HHS/FDA CDRH
Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Regular
Approved without change 06/25/2018
Retrieve Notice of Action (NOA) 05/22/2018
  Inventory as of this Action Requested Previously Approved
06/30/2021 36 Months From Approved 06/30/2018
118 0 118
1,416 0 1,416
0 0 0

This ICR collects information from manufacturers who wish to obtain information from FDA regarding the classification and regulatory requirements that may be applicable to their individual device. Under section 513 of the Federal Food, Drug, and Cosmetic Act, devices are classified by the regulatory controls needed to provide a reasonable assurance of their safety and effectiveness. FDA classifies these devices into class I (general controls), class II (special controls), or class III (premarket approval). Under section 513(g), within 60 days of receipt of a written request for information respecting the class in which a device has been classified or the requirements applicable to a device under the act, FDA will provide a written statement of classification (if any) of such device and the requirements of this act applicable to the device.

US Code: 21 USC 360c Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  82 FR 55381 11/21/2017
83 FR 16865 04/17/2018
No

2
IC Title Form No. Form Name
CBER 513(g) Requests
CDRH 513(g) Requests

  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 118 118 0 0 0 0
Annual Time Burden (Hours) 1,416 1,416 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$212,400
No
    No
    No
No
No
No
Uncollected
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.
05/22/2018


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