De Novo Classification Process (Evaluation of Automatic Class III Designation)

Forms and Documents

Document Name	Status
0844_Supporting Statement_2024.docx Supporting Statement A	2024-12-23

IC Document Collections

IC ID	Document Title	Status
227824	De Novo requests Other-De Novo Classification Process (Evaluation of Automatic Cl	Modified
227791	Withdrawal of de novo request Other-De Novo Classification Process (Evaluation of Automatic Cl	Modified

ICR Details

OMB Control No: 0910-0844	ICR Reference No: 202404-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202111-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: De Novo Classification Process (Evaluation of Automatic Class III Designation)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/03/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2025
Responses	84	73
Time Burden (Hours)	14,379	12,377
Cost Burden (Dollars)	5	5

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Abstract: The ICR describes the information collection involved with the De Novo classification process for medical devices. FDA uses the information in the De Novo request to evaluate whether the medical device may be reclassified from Class III to Class I or II, and if applicable, to determine the general and/or special controls necessary to sufficiently regulate the medical device. Respondents to the information collection are medical device manufacturers.

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Authorizing Statute(s): US Code: 21 USC 513 Name of Law: The FD&C Act; Classification of Devices Intended for Human Use
  

Citations for New Statutory Requirements: US Code: 21 USC 360c Name of Law: Classification of Devices Intended for Human Use

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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 46402	05/29/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 106512	12/30/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
De Novo requests
Withdrawal of de novo request

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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	84	73	0	0	11	0
Annual Time Burden (Hours)	14,379	12,377	0	0	2,002	0
Annual Cost Burden (Dollars)	5	5	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: We have provided the guidance document, “Electronic Submission Template for Medical Device De Novo Requests” with this request for approval. Given that all submissions were previously received electronically and the ability to voluntarily submit De Novo requests using eSTAR was included in the previous ICR, inclusion of the guidance in this ICR is not expected to impact the estimated burden. Our estimated burden for the information collection reflects an overall increase of 2,002 hours and a corresponding increase of 11 responses. We attribute this adjustment to an increase in the number of submissions received annually.

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Annual Cost to Federal Government: $6,974,440

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: 01/03/2025

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