Medical Device De Novo Classification Process

Forms and Documents

Document Name	Status
0844_Supporting Statement_Proposed Rule.doc Supporting Statement A	2019-04-16

IC Document Collections

IC ID	Document Title	Status
227824	De Novo request under 21 U.S.C. 513(f)(2)(ii) Other-Guidance:De Novo Classification Process (Evaluation of Aut	Removed
227791	Request for withdrawal Other-Guidance: De Novo Classification Process (Evaluation of Au	Modified
227790	(Burden Change Due to Rulemaking) De Novo Request Other-Guidance: De Novo Classification Process (Evaluation of Au	Modified

ICR Details

OMB Control No: 0910-0844	ICR Reference No: 201904-0910-011
Status: Historical Inactive	Previous ICR Reference No: 201707-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device De Novo Classification Process
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 04/29/2019
	Date Received in OIRA: 04/17/2019
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2020
Responses	57	0	57
Time Burden (Hours)	7,330	0	7,330
Cost Burden (Dollars)	0	0	0

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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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH53	Proposed rulemaking	83 FR 63127	12/07/2018

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Federal Register Notices & Comments

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 request under 21 U.S.C. 513(f)(2)(ii)
Request for withdrawal
(Burden Change Due to Rulemaking) De Novo Request

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Based on updated data and trends since the previous approval, we expect to receive approximately 60 De Novo requests per year; an increase of 8 respondents per year. There is no change to the currently approved burden estimate for “Written notice of withdrawal” of a De Novo request. However, we have updated the name of the IC to indicate that it is now under proposed 860.267(a)(4). The revisions described above increase the total burden estimate by 3,640 hours.

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Annual Cost to Federal Government: $5,406,100

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? 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: 04/17/2019

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