Reclassification Petitions for Medical Devices

Forms and Documents

Document Name	Status
0138--Reclassification Petitions--SS--.doc Supporting Statement A	2019-01-26

IC Document Collections

IC ID	Document Title	Status
5757	Reclassification Petitions for Medical Devices	Modified

ICR Details

OMB Control No: 0910-0138	ICR Reference No: 201812-0910-009
Status: Active	Previous ICR Reference No: 201806-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Reclassification Petitions for Medical Devices
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/01/2019
	Date Received in OIRA: 01/30/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	36 Months From Approved	09/30/2021
Responses	6	0	6
Time Burden (Hours)	2,982	0	3,000
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from medical device manufactures who wish to request reclassification of a medical device. A manufacturer may petition the Agency to reclassify a device. The reclassification procedures regulation requires a manufacturer to submit specific data when petitioning for reclassification. This includes both a "supplemental data sheet" (Form FDA 3427) and a "classification questionnaire" (Form FDA 3429). Each of these forms contains a series of questions concerning the safety and effectiveness of the device type. The regulation requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify.

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Authorizing Statute(s): US Code: 21 USC 360 ( e) ( f ) Name of Law: null
   US Code: 21 USC 360e (b) Name of Law: null
   US Code: 21 USC 360j(1) Name of Law: null
   US Code: 21 USC 360i(b)(1)(A) Name of Law: null
   US Code: 21 USC 360d(b) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH75	Final or interim final rulemaking	83 FR 64443	12/17/2018

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 16252	03/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 64443	12/17/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Reclassification Petitions for Medical Devices

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ICR Summary of Burden

	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	6	6	0	0	0	0
Annual Time Burden (Hours)	2,982	3,000	0	0	-18	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,561,716

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/30/2019

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