OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Premarket Approval of Medical Devices

ICR 202602-0910-004 · OMB 0910-0231 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
0231_Supporting Statement_2026.docx Supporting Statement A Uploaded 2026-07-14 Available
IC Document Collections
IC IDCollectionTypeStatusForm
5826 Premarket Approval of Medical Devices: Reporting Other-Agency Guidance - Providing Information about Pediatric Us Modified
257032 Certificate of Compliance w/42 CFR part 11 Modified
209459 Premarket Approval of Medical Devices: Maintenance of Records Modified
ICR Details
0910-0231 202602-0910-004
Received in OIRA 202211-0910-010
HHS/FDA CDRH
Premarket Approval of Medical Devices
Reinstatement without change of a previously approved collection   No
Regular 07/14/2026
  Requested Previously Approved
36 Months From Approved
45,699 0
1,211,556 0
0 0
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.
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
  
None
Not associated with rulemaking
  91 FR 18468 04/10/2026
91 FR 41042 07/06/2026
No
  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 45,699 0 0 0 41,663 4,036
Annual Time Burden (Hours) 1,211,556 0 0 0 858,676 352,880
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.
$58,310,000
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 [email protected]
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/14/2026