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OMB Control No: 0910-0231	ICR Reference No: 202602-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202211-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Approval of Medical Devices
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 07/14/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	45,699	0
Time Burden (Hours)	1,211,556	0
Cost Burden (Dollars)	0	0

Abstract: This information collection supports implementation of statutory requirements that govern premarket approval of medical devices. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Respondents to the information collection are PMA applicants, or persons who own the rights, or otherwise have authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity.

Authorizing Statute(s): US Code: 21 USC 360e, 360e-1 Name of Law: FFDCA; Premarket Approval
US Code: 21 USC 351(f) Name of Law: FFDCA; Adulterated Devices

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 18468	04/10/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 41042	07/06/2026
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	45,699	41,663	4,036
Annual Time Burden (Hours)	1,211,556	858,676	352,880
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 estimate is based on the annual rate of receipt of PMA submissions, including PDPs and PMA supplements, for fiscal years 2022 through 2024 and our expectation of submissions to come in the next few years. We also account for referrals of PMAs to a panel for review, as provided for under § 814.44(a). FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. We have adjusted our figures to reflect an overall decrease, which we attribute to respondents’ use of modernized submission technologies including eSTAR. At the same time, we include in our estimate an initial burden attributable to respondents who need to set up an eSTAR account for the first time. The regulations require the maintenance of records, which are used to trace patients, and the organization and indexing of records into identifiable files to ensure a device’s continued safety and effectiveness. These records are required of all applicants who have an approved PMA. Currently there are 860 active PMAs that could be subject to these requirements, based on FDA data, and approximately 33 new PMAs are approved each year. We estimate our annual recordkeeping burden based on an average of 860 PMA holders. The applicant determines which records should be maintained during product development to document and/or substantiate the device’s safety and effectiveness. Records required under 21 CFR part 820 may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device’s continuing safety and effectiveness. The overall burden increase of approximately 244% for reporting and 212% for recordkeeping represents a substantial change in the estimated regulatory burden for the PMA program. The increases are driven primarily by changes in estimated submission frequency rather than changes in the number of regulated entities or per-response burden estimates. The most significant factor is the dramatic increase in responses per respondent across multiple categories, particularly for 30-day notices (15× increase), PMA amendments (4× increase), pediatric information (6× increase), and eSTAR setup (6× increase). These changes suggest that the current estimates better capture the actual submission patterns and regulatory interactions that occur throughout the lifecycle of approved medical devices, reflecting more frequent modifications, updates, and communications between industry and FDA than were captured in the previous estimates based on 2019-2021 data.

Annual Cost to Federal Government: $58,310,000

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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