257,000
types of medical devices are available in the U.S.
FDA describes this as an approximate count in its 2024 safety report.
Source: FDA CDRH 2024 Safety Report, April 2024INDUSTRY REFERENCE
U.S. medical device regulation statistics: 2026
A current, sourced reference for medical-device teams, writers, and researchers tracking the scale, cost, and practical milestones behind U.S. device regulation.
Last updated September 18, 2026
AT A GLANCE
Numbers that put a device program in context.
This reference brings together current public FDA figures that are useful when planning, reporting on, or evaluating a medical-device program. Each statistic keeps its original reporting period and links directly to the source that published it.
FDA DATA
Market scale
The size and pace of the U.S. device environment set the context for every product program.
22,000
manufacturing facilities supply medical devices worldwide
FDA reports this as an approximate global count.
Source: FDA CDRH 2024 Safety Report, April 2024About 12
new or modified devices reach the U.S. market on an average business day
FDA's 2024 safety report uses this daily pace to describe its authorization work.
Source: FDA CDRH 2024 Safety Report, April 202430,380
annual establishment registrations were used in FDA's fiscal year 2027 fee calculation
This is FDA's three-year average for fiscal years 2023 through 2025, not a product count.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026FDA DATA
Product decisions
Specialized device programs can move quickly, but the route and evidence still need to fit the product.
76
oncology devices were authorized, cleared, or approved by FDA in 2024
FDA's Oncology Center of Excellence reported this total for the calendar year.
Source: FDA Oncology Regulatory Review: 2024, 2024 results3,128
current-good-manufacturing-practice inspections were planned across domestic and foreign drug and device establishments in fiscal year 2024
This FDA work-plan total covers both drug and device establishments.
Source: FDA Fiscal Year 2024 Work Plan, Fiscal year 2024FDA DATA
Fees and filing
Current FDA fees and filing requirements shape the budget and timing assumptions behind a U.S. submission plan.
$13,785
annual establishment registration fee for fiscal year 2027
FDA lists this fee separately from premarket submission fees.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026$28,653
standard 510(k) submission fee for fiscal year 2027
Small-business rates can differ when eligibility requirements are met.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026$191,020
standard De Novo classification request fee for fiscal year 2027
FDA publishes this as the standard fee for the fiscal year.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026$636,732
standard premarket approval application fee for fiscal year 2027
The fee applies to a standard PMA application and differs from other PMA-related submissions.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026FDA DATA
Filing volume
FDA's fee schedule also shows the recent volume assumptions used to set standard submission fees.
1,860
annual standard-fee 510(k) submissions in FDA's fiscal year 2023 through 2025 average
This is the three-year average of fee-paying submissions used in FDA's fiscal year 2027 fee calculation.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 202622
annual standard-fee De Novo requests in FDA's fiscal year 2023 through 2025 average
This is a fee-calculation average, not the total number of all De Novo requests FDA received.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 202628
annual full-fee PMA applications in FDA's fiscal year 2023 through 2025 average
This is the three-year average of full-fee applications used for the fiscal year 2027 fee schedule.
Source: FDA Medical Device User Fee Rates for Fiscal Year 2027, July 30, 2026FDA DATA
Electronic submissions
FDA's structured submission tools have become a fixed part of the filing process for major pathways.
Oct. 1, 2023
was the FDA deadline for electronic 510(k) submissions through eSTAR
FDA states that 510(k) submissions must be sent electronically through eSTAR.
Source: FDA CDRH Portal and eSTAR, March 2026Oct. 1, 2025
was the FDA deadline for electronic De Novo classification requests through eSTAR
FDA identifies eSTAR as the required electronic submission route for De Novo requests.
Source: FDA CDRH Portal and eSTAR, March 2026Mar. 8, 2026
is the FDA's listed eSTAR update date for PMA applications and related premarket submissions
The CDRH Portal page lists eSTAR support for PMA applications, Q-Submissions, and other submission types.
Source: FDA CDRH Portal and eSTAR, March 2026SOURCES AND METHOD
Built for accurate citation, not broad estimates.
All figures on this page come from named FDA sources. Some describe calendar-year results, some cover fiscal-year activity, and others are dated filing milestones. They are shown as published and are not combined into a single estimate.
- FDA CDRH 2024 Safety ReportApril 2024
- FDA Fiscal Year 2024 Work PlanFiscal year 2024
- FDA Oncology Regulatory Review: 20242024 results
- FDA Medical Device User Fee Rates for Fiscal Year 2027July 30, 2026
- FDA CDRH Portal and eSTARMarch 2026
Cite this page
Qualira. U.S. Medical Device Regulation Statistics: 2026. Updated September 18, 2026. https://qualira.com/medical-device-regulatory-statistics