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OMB Control No: 0910-0078	ICR Reference No: 202505-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202210-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Investigational Device Exemptions
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: 02/27/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2026
Responses	12,611	11,578
Time Burden (Hours)	75,822	65,903
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	12,611	11,578	1,033
Annual Time Burden (Hours)	75,822	65,903	9,919
Annual Cost Burden (Dollars)	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 overall increase of 9,919 hours and a corresponding increase of 1,033 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

Annual Cost to Federal Government: $31,517,664

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

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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