Certificate of Need (CON) for Medical Devices: State-by-State Guide

State-by-state guide to Certificate of Need (CON) rules for capital medical devices. Map reviewable equipment, thresholds, and sales strategy.

Scenario: Gating Capital Equipment Sales at the State Border

Imagine your commercial team has spent six months negotiating the sale of a state-of-the-art PET/CT scanner or a linear accelerator to a hospital or an ambulatory surgery center (ASC) in Georgia, North Carolina, or New York. The clinical champions are on board, the hospital value analysis committee (VAC) has approved the clinical utility, and the group purchasing organization (GPO) contract is in place. But as the contract goes to signing, the hospital’s legal counsel halts the transaction with a single question: "Have we secured a Certificate of Need (CON) or a reviewability determination from the state?"

If the answer is no, the transaction cannot close. The buyer faces severe administrative penalties, loss of facility licensing, or exclusion from state Medicaid reimbursement if they acquire the device without state approval. For the manufacturer, this means the sales cycle is suddenly extended by six to twelve months, with the very real risk that the state planning board will deny the purchase altogether or that a competitor hospital will formally challenge the application.

This guide provides a comprehensive, data-driven map of Certificate of Need laws from the perspective of medical device manufacturers and commercial teams. It outlines which states require a CON for major medical equipment, the specific device categories affected (PET is the most commonly named reviewable category across the CON states), the dollar thresholds that trigger review, and how to build CON compliance directly into your demand planning and sales forecast.

What is a Certificate of Need (CON) and How Does It Gate Medical Devices?

A Certificate of Need (CON) is a state-level regulatory permit required before a healthcare provider can establish a new facility, expand services, or make major capital expenditures—including purchasing high-cost medical devices.

First established at the federal level under the National Health Planning and Resources Development Act of 1974, CON programs were intended to control healthcare costs by preventing the over-accumulation of redundant, expensive medical technologies. Congress repealed the federal mandate in 1986, leaving CON policies entirely to the discretion of individual states. Today, the legislative landscape is highly fragmented:

CON Jurisdictions: We count 37 active jurisdictions (36 states plus the District of Columbia) that operate an active CON or equivalent health-planning review program.
Non-CON States: Approximately 14 states have repealed their CON laws entirely (including California, Texas, and Pennsylvania), relying instead on market competition and standard licensing to control supply.
Capital Equipment Focus: In the states that retain CON laws, state health planning agencies regulate the acquisition of "Major Medical Equipment." This means that even if a facility is fully licensed, it cannot buy, lease, or otherwise acquire specific high-cost diagnostic or therapeutic devices without demonstrating to the state that there is a documented community need for that technology.

For medical device manufacturers, CON represents a critical, upstream market-access gate. It is a legal barrier that sits outside the hospital's procurement process. If a state denies a CON, the provider is legally prohibited from acquiring the device.

The 37 Active CON Jurisdictions

Based on official state health-planning codes and statutes, the following 37 jurisdictions maintain active CON programs that regulate capital medical equipment purchases, facility expansions, or specialized service additions:

Northeast & Mid-Atlantic: Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Jersey, New York, Rhode Island, Vermont, West Virginia.
South: Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Virginia.
Midwest: Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Nebraska, Ohio.
West: Alaska, Hawaii, Montana, Nevada, Oregon, Washington.

(Note: States like Indiana and Ohio operate highly narrowed reviews focused primarily on nursing homes or specific facility types, while states like North Carolina, Georgia, New York, and Washington maintain broad, aggressive review frameworks covering a wide range of capital medical equipment categories.)

Medical Device Category-by-State Matrix

The scope of regulated equipment varies widely. While some states trigger review based purely on a flat capital expenditure threshold (e.g., any equipment acquisition exceeding $3 million), most states list specific regulated device categories regardless of the purchase price.

Through analysis of official state agency rules and statutes, we mapped the review requirements for seven major capital medical equipment categories across the active CON states.

To show where device-specific review concentrates, we scanned the official state CON program pages and statutes crawled for the 37 active jurisdictions (2025–2026 stamp) for explicit mentions of seven major capital equipment categories. A keyword hit means the state names that category as reviewable on its own program materials; states that regulate only through a flat dollar threshold, or that bury device lists in service-specific rule chapters we did not fully extract, will not appear even though they may still review the equipment. Treat the counts below as conservative "at least" floors, not exhaustive coverage.

Device Category	Device-Level Review Frequency	CON States Naming the Category (scanned program pages)
PET / PET-CT scanners	Most frequently named category; reviewable in at least 14 of the 37 jurisdictions.	AK, AR, CT, HI, IA, IL, KY, MA, MI, MO, MS, NJ, TN, WV
MRI scanners	Named at the device level in roughly 15 jurisdictions; elsewhere caught only by the dollar threshold.	AK, CT, HI, IA, KY, MA, MI, MO, MS, NJ, NY, TN, VA, VT, WV
CT scanners	Named at the device level in roughly 11 jurisdictions.	AK, CT, HI, IA, MI, MO, MS, NY, TN, VT, WV
Linear accelerators (radiation therapy)	Device-level review in at least 11 jurisdictions.	AK, CT, HI, IA, IL, MS, MO, NY, TN, VA, VT
Cardiac catheterization labs	Device-level review in at least 13 jurisdictions.	AK, FL, HI, IA, IL, KY, MI, MO, MS, NJ, NY, TN, WV
Lithotripsy (ESWL)	A niche reviewable category in at least 4 jurisdictions.	HI, MI, MO, NY
Gamma Knife / CyberKnife (stereotactic radiosurgery)	Named in about 5 jurisdictions.	AK, HI, MO, TN, VA

Analysis of Regulated Categories:

Positron Emission Tomography (PET): PET and PET/CT scanners are the most commonly named device category. Of the 37 active CON jurisdictions, roughly 18 explicitly name at least one device category on their program pages, and PET appears in at least 14 of them — more than any other equipment type. Because PET is a highly specialized, high-cost oncological and neurological diagnostic service, states that list specific equipment almost always include it. Note that several additional states capture PET through a general capital-expenditure threshold rather than a named category, so real-world PET review coverage is wider than the named-category count suggests.
Magnetic Resonance Imaging (MRI) and Computed Tomography (CT): MRI and CT scanners are named at the device level in roughly 11 to 15 states. In other CON states, they are subject to review only if the total acquisition cost (including installation and site prep) exceeds the state's general capital expenditure threshold. Some states (notably North Carolina, as discussed below) are simultaneously narrowing MRI review by population-based county exemptions.
Linear Accelerators (Radiation Therapy): Radiation oncology equipment is subject to strict, device-level CON review in at least 11 jurisdictions (Alaska, Connecticut, Hawaii, Iowa, Illinois, Mississippi, Missouri, New York, Tennessee, Virginia, and Vermont). Note that Tennessee's 2024 reform legislation schedules the linear accelerator CON requirement for removal effective December 1, 2027.
Lithotripsy: Extracorporeal shock wave lithotripters (ESWL) are regulated as a specialized technology in at least 4 jurisdictions (Hawaii, Michigan, Missouri, and New York). In these states, buying a lithotripter can require a CON even if the device cost is modest compared to an MRI or PET scanner.
Cardiac Catheterization: Equipment used to establish or expand cardiac catheterization laboratories is regulated in at least 13 jurisdictions, reflecting a regulatory effort to control the spread of invasive cardiac services.

Understanding CON Thresholds in Key States

In addition to technology-specific lists, states establish dollar thresholds. If a medical device purchase—or the project associated with it—exceeds this threshold, it triggers a mandatory CON review. The calculation is not limited to the manufacturer's invoice price for the device; it must include delivery, installation, software licensing, site preparation, construction, and any associated facility modifications.

Here is an analysis of how major device markets structure these gates:

1. New York

New York maintains one of the nation's most comprehensive and rigorous CON programs under the Department of Health (DOH).

Capital Threshold: The general threshold for capital projects is approximately $6 million, but major medical equipment has specific rules.
Device Rules: Acquisition of clinical equipment (such as MRI, CT, PET, and linear accelerators) by a hospital or diagnostic and treatment center triggers review. Under New York Public Health Law Section 2802, even private physician practices acquiring "advanced imaging equipment" must submit a notification to the DOH, and in many cases, are subject to CON if the equipment will serve a broader community need or exceed cost limits.

2. Georgia

Georgia's CON program is administered by the Department of Community Health (DCH) under Georgia Code Section 31-6-40. The landscape shifted materially with House Bill 1339, signed April 19, 2024 and effective July 1, 2024.

Dollar Thresholds Largely Removed: HB 1339 deleted the capital-expenditure and equipment-expenditure thresholds from the statute. It removed the $10 million hospital capital-expenditure threshold (set in 2019) and removed the prior $3 million cost limit on imaging-equipment acquisitions by hospitals and physician practices. As a result, many equipment acquisitions no longer trigger CON purely by cost.
Device Categories Still Reviewable: Despite removing the dollar gates, Georgia still requires CON for offering or expanding specific clinical services — including radiation therapy, surgical services, biliary lithotripsy, and cardiac catheterization — and for establishing or expanding facilities. Ambulatory surgery centers gained expanded exemptions under HB 1339, with separate construction-cost references retained in rule 111-2-2.
Aggregated Costs Still Matter for Reviewable Projects: Although the dollar thresholds are gone, Georgia rule 111-2-2-.06 still aggregates all costs associated with a reviewable project. For projects that do remain subject to CON (for example, a new cardiac catheterization service), delivery, installation, shielding, and site-prep costs are all counted together when the agency evaluates the application.

3. North Carolina

North Carolina's Department of Health and Human Services (DHHS) operates a highly active CON section.

Major Medical Equipment definition: North Carolina General Statutes Section 131E-176(14o) defines major medical equipment with a specific statutory threshold (currently adjusted to approximately $2.0 million).
Category Triggers: Regardless of cost, the acquisition of specific "uniquely controlled" assets—including MRI scanners, PET scanners, linear accelerators, simulators, cardiac catheterization equipment, and lithotripters—requires a CON. A provider cannot buy a used MRI scanner for $100,000 without clearing the CON gate first.

4. Tennessee

Tennessee's Health Facilities Commission (HFC) administers one of the more restrictive CON programs, regulating roughly 20 distinct services and device categories (TN Code § 68-11-1602 et seq.).

Category-Based, Not Threshold-Based: Rather than gating equipment by a single dollar figure, Tennessee requires a CON before a provider begins specific enumerated services — including adding MRI (in counties under 250,000 population, with pediatric MRI reviewed statewide), PET, linear accelerator, cardiac catheterization, open heart surgery, burn units, and NICUs — regardless of the purchase price of the underlying hardware.
Ongoing Rollback: Tennessee's 2024 reform legislation began removing specific categories from CON: the linear accelerator requirement is scheduled to end December 1, 2027, open heart surgery on December 1, 2029, and new acute-care hospitals will no longer need a CON starting in July 2028. Manufacturers selling radiation-therapy and cardiac-surgery capital equipment into Tennessee should track these phase-out dates closely, because each removal opens a new demand window.

The CON Application Taxonomy & Review Process

When a medical device acquisition triggers a CON, the transaction enters a formal administrative process. Manufacturers must understand the taxonomy of applications and the procedural stages, as they dictate the timeline of the sales cycle.

+--------------------------------------------------------------+
|                1. PREPARATION & FILING                       |
|   Provider drafts application; includes manufacturer specs,  |
|   clinical justification, and financial projections.         |
+--------------------------------------------------------------+
                               |
                               v
+--------------------------------------------------------------+
|                 2. COMPLETENESS REVIEW                       |
|   State agency reviews application for missing data.         |
|   Can issue Requests for Information (RFIs) delaying start.   |
+--------------------------------------------------------------+
                               |
                               v
+--------------------------------------------------------------+
|                 3. BATCHING & REVIEW CYCLE                   |
|   Application is placed in a review cycle (often quarterly).  |
|   State planners evaluate demand, local capacity, and cost.  |
+--------------------------------------------------------------+
                               |
                               v
+--------------------------------------------------------------+
|            4. PUBLIC HEARINGS & CHALLENGES                   |
|   Public notice is given. Competitor hospitals can submit    |
|   opposition letters, demand public hearings, or challenge.  |
+--------------------------------------------------------------+
                               |
                               v
+--------------------------------------------------------------+
|                 5. ADMINISTRATIVE DECISION                   |
|   State agency approves, approves with conditions, or denies |
|   the Certificate of Need.                                   |
+--------------------------------------------------------------+
                               |
                               v
+--------------------------------------------------------------+
|                    6. APPEALS PROCESS                        |
|   Denied applicants or aggrieved competitors can appeal to    |
|   administrative law judges or state courts (takes 1-2 years).|
+--------------------------------------------------------------+

The Application Taxonomy:

Depending on the state and the project scope, providers file under different application categories:

Full Certificate of Need: Required for new services, new facilities, or equipment purchases exceeding major medical equipment thresholds. Involves full comparative review, public comment, and formal agency decisions. Takes 6 to 12 months on average.
Equipment Replacement Request: Many states offer an expedited or simplified review path if a provider is replacing an existing, fully approved medical device (e.g., replacing an older 1.5T MRI with a new 3.0T MRI). To qualify, the old equipment must be decommissioned, taken out of service, and disposed of. These requests are often approved within 30 to 60 days.
Reviewability Determination / Declaratory Ruling: If a provider believes a project does not trigger CON (e.g., the total project cost is verified to be under the threshold, or a private office is adding a diagnostic service not explicitly regulated), they can request a formal ruling from the state agency. Securing a "Letter of Non-Reviewability" provides legal protection before the provider signs a purchase contract.
Emergency CON: In rare circumstances (such as natural disasters or the sudden failure of a region's only radiation therapy machine), states can issue temporary, emergency CON approvals within 24 to 72 hours.
Change of Ownership (CHOW): If a hospital is acquired or enters a joint venture, the existing CONs for its major medical equipment must be formally transferred, which requires administrative approval.

How CON Affects the Device Sales Cycle & Commercial Strategy

For capital equipment manufacturers, ignoring CON laws during the pipeline generation phase is a major operational risk. If a sales representative forecasts a deal to close in Q4, but the customer has not even filed a CON application, that deal is highly likely to slip.

Here is how commercial leaders should build CON mitigation into their sales operations and commercial strategies:

1. Account Qualification and Pipeline Scrutiny

Your CRM pipeline must include CON-specific tracking fields for accounts in the 37 CON jurisdictions:

Does this project exceed the state's major medical equipment or capital expenditure threshold?
Does this state regulate this specific technology (e.g., PET, MRI, Linear Accelerator) at the device level?
What is the account's history with the state CON board? Do they have a dedicated regulatory counsel?
Has a Request for Reviewability Determination been filed, or is a full CON application required?

If a sales representative cannot answer these questions, the deal's close date is unverified.

2. Factoring Competitor Challenge Risk

In many CON states (such as Georgia, North Carolina, and Virginia), the application process is highly adversarial. When a provider applies to add an MRI or a PET scanner, the state must publish a public notice. Local competitor hospitals and health systems have the legal right to submit opposition letters, present conflicting data showing that the region has excess capacity, and demand formal administrative hearings.

Competitors use CON challenges as a strategic tool to protect their market share and delay rivals. A competitor challenge can easily add 12 to 24 months of legal proceedings to a device sale. Manufacturers must work with their customer's legal and planning teams to assemble robust clinical utilization data, showing that local patients are currently facing long wait times or travel distances, to pre-empt and defeat competitor objections.

3. Joint Venture and Outpatient Strategies

Because CON programs focus heavily on hospital capital budgets and institutional licensing, some manufacturers and providers seek to place equipment in private, physician-owned offices or outpatient clinics.

The Private Office Exception: Historically, several states exempted private physician offices from CON review, allowing them to buy MRI or CT scanners for their own patients.
Regulatory Closure: State legislators have increasingly closed this loophole. For example, states like Georgia and North Carolina now require private offices to secure approvals or limit their equipment costs to strict thresholds.
Dual-Use Pitfalls: If a private office shares its imaging equipment with an adjacent hospital or bills under a hospital's provider number, regulators will treat the arrangement as a regulated hospital service, exposing both parties to penalties for non-compliance.

4. Supporting Customer Applications with Technical Evidence

Manufacturers should not write the CON application for the customer, as this can raise legal and anti-kickback compliance issues. However, manufacturers can and should provide the customer with objective technical and economic data to support their filing:

Detailed equipment specifications, installation requirements, and itemized pricing (to establish the exact baseline cost).
Evidence comparing the diagnostic or therapeutic capabilities of the new system against legacy systems (e.g., showing how a new linear accelerator reduces treatment times, allowing more patients to be treated per day).
Data demonstrating the energy efficiency, shielding requirements, and physical footprint of the device (critical for calculating construction and site prep costs).
Case studies and peer-reviewed literature demonstrating the clinical outcomes and cost-effectiveness of the technology.

Recent Legislative Shifts: States Repealing or Narrowing CON Laws

The regulatory landscape is not static. Over the past decade, there has been a significant legislative pushback against CON programs, driver by research suggesting that CON laws restrict access, reduce provider competition, and fail to lower healthcare costs.

South Carolina (2023 Repeal): In 2023, South Carolina enacted S.164, signed by Governor McMaster, which eliminated CON requirements for almost all healthcare facilities and most equipment categories. The repeal took effect immediately for ambulatory surgery centers and most services, instantly opening South Carolina as a competitive market for MRI, CT, PET, and cardiac catheterization sales. New acute-care hospital construction and bed expansions remained under CON until January 1, 2027; nursing homes and home health agencies continue to require a CON.
North Carolina (2024-2026 Phase-In): As part of the 2023 budget agreement, North Carolina enacted provisions to ease CON restrictions. Specifically, the state agreed to eliminate CON requirements for ambulatory surgery centers (ASCs) and MRI scanners in counties with populations exceeding 125,000, phased in over several years (running through 2026). This has sparked a surge in outpatient development and capital equipment purchasing in metropolitan areas like Charlotte and Raleigh-Durham.
West Virginia (Ongoing Narrowing): West Virginia has passed multiple legislative bills since 2021 that exempt specific services and capital equipment from CON review, particularly for hospital-based expansions and outpatient imaging services under set limits.
The Federal Anti-Trust Stance: The Federal Trade Commission (FTC) and the Department of Justice (DOJ) have repeatedly issued joint statements urging states to repeal or narrow their CON laws, arguing that they act as anticompetitive barriers that protect incumbent providers from new market entrants.

For commercial planning, device manufacturers must monitor these legislative sessions. When a state repeals or significantly narrows its CON law, it creates a high-velocity sales window. Incumbent providers rush to upgrade outdated equipment, and independent groups move quickly to build new outpatient clinics and ASCs before the market becomes saturated.

Frequently Asked Questions (FAQs)

Does CON apply to replacement equipment or only new purchases?

In most CON states, replacing an existing, fully approved medical device is exempt from a full CON review, provided the replacement does not expand the facility's licensed capacity or add entirely new clinical services. However, providers must typically file an expedited Equipment Replacement Request or Notification of Replacement with the state planning agency. This process requires proving that the old device will be completely decommissioned and removed from the state's active inventory to prevent "capacity doubling." If the replacement equipment adds a new clinical capability (e.g., replacing a diagnostic CT with a treatment-planning CT), some states may still require a full review.

Can a competitor or incumbent hospital challenge our CON application?

Yes. In approximately 20 of the 37 active CON jurisdictions, the administrative process allows for formal competitor intervention. Once a provider submits a CON application, a public notice period begins. Any "affected party"—which is legally defined to include competing hospitals, clinics, or physician groups operating within the same service area—can submit formal written objections, present testimony at public hearings, and appeal a state approval. Incumbents frequently use these challenges to delay competitors, protect their service volumes, and exhaust their rivals' financial resources.

What dollar threshold triggers CON for imaging equipment in major states such as NY, FL, and GA?

New York: Virtually all major medical equipment acquisitions at licensed hospitals or clinics require DOH approval. Private offices must notify the state for advanced imaging, and projects exceeding general capital limits (roughly $6 million) trigger full reviews.
Georgia: Georgia's 2024 reform (HB 1339, effective July 1, 2024) removed the dollar thresholds for equipment acquisitions — including the prior $3 million imaging-equipment cost limit for hospitals and physician practices. CON is still required for adding specific reviewable services such as radiation therapy, cardiac catheterization, and biliary lithotripsy, regardless of equipment cost.
Florida: Florida repealed most of its CON program in 2019 via HB 21 (signed June 26, 2019). General hospitals, complex medical rehabilitation beds, and tertiary hospital services — including transplant programs, open-heart surgery, and imaging such as MRI and CT — no longer require a CON; specialty hospitals followed on July 1, 2021. Florida now retains CON only for a narrow set of long-term-care facilities (skilled nursing facilities, hospices, and intermediate care facilities for individuals with developmental disabilities), so capital imaging and therapy-equipment sales there are essentially ungated.

Are ambulatory surgery centers (ASCs) subject to CON?

Yes, in approximately 26 of the 37 CON jurisdictions, establishing a new ambulatory surgery center or adding surgical operating rooms to an existing facility requires a Certificate of Need. Because ASCs compete directly with hospital outpatient departments (HOPDs) for high-margin outpatient surgeries, ASC CON applications are among the most heavily contested filings in the industry. Device manufacturers looking to sell surgical suites or capital systems to new ASCs must verify that the center has secured its facility-level CON before finalizing equipment contracts. (For more details on ASC commercial dynamics, see our guide on ambulatory surgery center expansion and device commercialization).

Practical Action Plan for Device Manufacturers

To navigate Certificate of Need barriers successfully, capital medical device companies should implement the following four-part action plan:

Map CON Gates to Your Sales Territories: Ensure your regional sales directors and account managers are trained on the specific CON regulations, equipment lists, and dollar thresholds of the states in their territories. Treat CON as a standard qualification step in your sales process.
Audit the Cost of the Entire Project: Work closely with the customer's facilities and engineering teams early in the deal cycle. Do not look only at the device invoice. Get estimates for shielding, structural reinforcement, HVAC upgrades, and installation. If the total project cost is close to a state's threshold, advise the customer to consult regulatory counsel to determine if a Reviewability Determination or a full CON is required.
Optimize the Decommissioning Process for Replacements: Since replacement equipment is easier to clear than new equipment, offer turnkey decommissioning services. Provide the customer with certified documentation proving that their old scanner has been disassembled, exported, or scrapped. This documentation is critical for clearing their state replacement notifications.
Align with Internal Policy Experts: Coordinate your sales strategy with your company's market-access and government-affairs teams. These teams monitor state legislative sessions and can provide early warnings when a state is preparing to retire or narrow its CON program, allowing you to reallocate commercial resources to take advantage of new market opportunities.

For further reading on navigating hospital-side buying barriers and GPO contracting, see our guide on hospital value analysis committees and GPO device access. To understand the difference between facility-level capital gates and payer-level reimbursement coverage, refer to our detailed breakdown of Medicare NCD vs LCD coverage determination.