Reclassification Petitions for Medical Devices

Forms and Documents

Document Name	Status
0138--ReclassPetitions--SSA for ROCIS 11-04-24.docx Supporting Statement A	2024-11-06

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: 202406-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202201-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Reclassification Petitions for Medical Devices
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/20/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2025
Responses	12	6
Time Burden (Hours)	5,964	2,982
Cost Burden (Dollars)	0	0

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Abstract: This information collection helps to implement section 515 (21 U.S.C. 360e) of the Federal Food, Drug, and Cosmetic Act, with regard to the reclassification of medical devices. Section 515 provides, among other things, that, upon petition, a manufacturer may request that FDA reclassify a medical device. Accordingly, we have established reclassification procedures consistent with statutory requirements that set forth format and content elements.

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Authorizing Statute(s): US Code: 21 USC 360c(e) Name of Law: Classification of devices intended for human use
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 56390	07/09/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 102910	12/18/2024
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 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	12	6	0	0	6	0
Annual Time Burden (Hours)	5,964	2,982	0	0	2,982	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: Our estimated burden for the information collection reflects an increase of 6 responses and a corresponding increase of 2,982 hours. We attribute this adjustment to an increase in the average number of submissions per year we received over the last few years.

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Annual Cost to Federal Government: $2,092,326

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? No

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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: 12/20/2024

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