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

Forms and Documents

Document Name	Status
0844 De Novo Device Classifications SSA DEC 2021.docx Supporting Statement A	2021-12-02
FRIA De Novo Device Classification Process OCT 2021.pdf Supplementary Document	2021-11-22

IC Document Collections

IC ID	Document Title	Status
236833	Recommended Content Checklist Other-Guidance: De Novo Classification Process (Evaluation of Au	Removed
236831	Acceptance Checklist Other-Guidance: De Novo Classification Process (Evaluation of Au	Removed
227824	De Novo requests Other-Guidance:De Novo Classification Process (Evaluation of Aut	Modified
227791	Withdrawal of de novo request Other-Guidance: De Novo Classification Process (Evaluation of Au	Modified
227790	De Novo request under 21 U.S.C. 513(f)(2)(i) Other-Guidance: De Novo Classification Process (Evaluation of Au	Removed

ICR Details

OMB Control No: 0910-0844	ICR Reference No: 202111-0910-009
Status: Received in OIRA	Previous ICR Reference No: 201905-0910-006
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: 12/02/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2022
Responses	73	185
Time Burden (Hours)	12,377	10,730
Cost Burden (Dollars)	5	7,283

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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:
0910-AH53	Final or interim final rulemaking	86 FR 54826	10/05/2021

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Acceptance Checklist
De Novo request under 21 U.S.C. 513(f)(2)(i)
De Novo requests
Recommended Content Checklist
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	73	185	-112	0	0	0
Annual Time Burden (Hours)	12,377	10,730	1,647	0	0	0
Annual Cost Burden (Dollars)	5	7,283	-7,278	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: The information collection includes program changes and adjustments. Consistent with estimates found in our analysis of impacts for RIN 0910-AH53, we have increased our estimate of the total number of respondents since last OMB review and approval. Also, the burden we previously attributed to guidance instruction regarding De Novo classification requests and withdrawals, we now attribute to requirements found in agency regulations. However, in our estimated burden per response for a De Novo request, we continue to account for burden that may be associated with completion of the Acceptance Checklist. Finally, we have corrected an inadvertent error found in our proposed rulemaking. Cumulatively, these changes and adjustments result in an overall annual increase of burden by 1,647 hours and decrease of responses by 112.

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Annual Cost to Federal Government: $5,626,100

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: 12/02/2021

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