Medical Device Labeling Regulations

Forms and Documents

Document Name	Status
0485 Change Request to include 0577 GFI JUNE 2021.docx Justification for No Material/Nonsubstantive Change	2021-06-16
0485_Supporting Statement_2018.doc Supporting Statement A	2018-09-12

IC Document Collections

IC ID	Document Title	Status
247934	Medical Device Labeling; Submission of IVD Symbols Glossary Other-Agency Guidance	New
232983	Medical Device Labeling Regulations; Third-Party Disclosure Other-Agency Guidance	Modified
232982	Medical Device Labeling Regulations; Recordkeeping	Unchanged

ICR Details

OMB Control No: 0910-0485	ICR Reference No: 202106-0910-007
Status: Received in OIRA	Previous ICR Reference No: 201808-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device Labeling Regulations
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/16/2021

	Requested	Previously Approved
Expiration Date	10/31/2021	10/31/2021
Responses	81,912,634	81,908,682
Time Burden (Hours)	12,304,335	12,289,240
Cost Burden (Dollars)	0	0

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Abstract: This ICR collects information from manufacturers, importers, and distributors of medical devices to disclose to health professionals and consumers specific information about themselves or their devices on the label or labeling of their devices. The primary users of the information disclosed on the label or in the labeling of devices are the health professionals who use or prescribe the device or the lay consumers who use the device. The labeling should contain sufficient information for these persons to use the device safely and effectively. FDA may use the information to determine whether there is reasonable assurance of the safety and effectiveness of the device for its intended use.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: FD&C Act
  

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:
	83 FR 7728	02/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 44884	09/04/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Medical Device Labeling Regulations; Recordkeeping
Medical Device Labeling Regulations; Third-Party Disclosure
Medical Device Labeling; Submission of IVD Symbols Glossary

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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	81,912,634	81,908,682	0	0	3,952	0
Annual Time Burden (Hours)	12,304,335	12,289,240	0	0	15,095	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: $2,573,850

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.     No

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: 06/16/2021

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