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Attention: FDA Reclassifies 8 Class III Medical Devices to Class II in 2026!

Time：2026-08-18 14:04:16

For medical device companies expanding into the U.S. market, product classification directly determines the market access pathway, timeline and costs: Class I devices only require general controls, Class II devices obtain market entry via 510(k) clearance, while Class III devices must undergo the rigorous Premarket Approval (PMA) process.As technology evolves and clinical evidence accumulates, the FDA dynamically adjusts device regulatory classifications through the reclassification mechanism. Many high-risk device categories have been downgraded via this process, significantly lowering market entry barriers.

Recently, the FDA updated the full list of reclassifications by the Center for Devices and Radiological Health (CDRH) since 2013. As of August 2026, a total of 51 device reclassifications have been completed, among which 8 Class III devices have been officially downgraded to Class II in 2026.

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https://www.fda.gov/about-fda/cdrh-transparency/reclassification

一、Three Statutory Pathways for Medical Device Reclassification

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), there are three statutory procedures for medical device reclassification, each applicable to different scenarios with distinct initiating parties and review processes.

（一）Section 513(e): General Reclassification Pathway for Classified Devices

This is the FDA’s core and most commonly used reclassification pathway, intended for mature device types with established formal classifications. Following the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, this pathway shifted from a rulemaking process to an administrative order process, markedly improving review efficiency.

Initiation：The FDA may initiate reclassification on its own initiative, or in response to a reclassification petition submitted by an interested party.

Core prerequisite：New valid scientific evidence regarding the device must be available, demonstrating that the existing classification level does not match the actual risk profile of the product.

Statutory process：Publish a proposed order in the Federal Register → convene a device classification panel meeting → solicit public comments → issue a final order.

Classification determination logic：For proposed upgrade from Class II to Class III: Evidence must show that general controls and special controls together are insufficient to provide reasonable assurance of the device’s safety and effectiveness.

For proposed downgrade from Class III to Class II: Evidence must show that general controls and special controls together are sufficient to provide reasonable assurance of the device’s safety and effectiveness.
For proposed downgrade from Class II/III to Class I: Evidence must show that general controls alone are sufficient to provide reasonable assurance of the device’s safety and effectiveness.

（二）Section 513(f)(3): Special Reclassification for Postamendments Class III Devices

Devices marketed after the enactment of the Medical Device Amendments in 1976 (referred to as postamendments devices) are automatically classified as Class III without FDA rulemaking. Such devices may apply for classification adjustment through this pathway.

Initiation：Initiated by the FDA on its own, or by petition from a manufacturer or importer.

Core requirement：The regulatory controls corresponding to the proposed new class must be sufficient to provide reasonable assurance of the device’s safety and effectiveness for its intended use.

Review process：The FDA may refer the petition to a device classification panel for review and recommendation. After evaluating all information, the FDA will issue an order approving or denying the petition.

（三）Section 513(f)(2): De Novo Classification Pathway

Commonly known as the De Novo pathway, this was added by the Food and Drug Administration Modernization Act (FDAMA) of 1997. Amended by FDASIA in 2012, sponsors may submit a De Novo classification request directly to the FDA without first submitting a 510(k) and receiving a "not substantially equivalent" (NSE) determination.

Applicable scenario：Novel low-to-moderate risk medical devices with no existing predicate device on the market, which cannot be cleared via the 510(k) pathway.

Nature：It serves as the initial classification for novel devices, and in a broad sense qualifies as a reclassification pathway. It can downgrade novel devices automatically classified as Class III to Class I or Class II.

二、Overview of CDRH Reclassification Data

Pursuant to Section 608(c) of the FDASIA, the FDA is required to publicly disclose the number and types of reclassified devices for the previous calendar year on an annual basis.

From 2013 (the first full calendar year after FDASIA enactment) to August 2026, CDRH has completed a total of 51 medical device reclassifications. The overall trend features far more downgrades than upgrades:

41 downgrades from Class III to Class II or Class I, accounting for over 80% of total reclassifications
10 upgrades from Class I/II to Class II/III
No new reclassification projects in 2022 and 2023

（一）Annual Trend

2016 saw the highest annual volume, with 12 adjustments completed, 10 of which were Class III downgrades.
2021 recorded 8 adjustments, marking the year with the most upgrades (5 upgrades and 3 downgrades).
As of August 2026, 8 adjustments have been completed, all being downgrades from Class III to Class II — the highest number of annual downgrades in recent years.

（二）Notable Upclassification Cases

Upclassifications are mostly driven by explicit safety risk considerations. High-profile cases in the industry include:

2016: Synthetic and non-synthetic surgical mesh for transvaginal pelvic organ prolapse repair, upgraded from Class II to Class III.
2021: Internal surgical staplers and multiple types of blood lancets, upgraded from Class I to Class II.

三、Latest Updates in 2026

The FDA has issued 8 final reclassification orders in 2026 to date, all downgrading devices from Class III to Class II, covering three major fields: adjunctive dermatological diagnosis, physical rehabilitation, and oncology companion diagnostics. The detailed list is as follows:

Note: The aforementioned skin diagnostic devices are collectively classified as "Software-aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer". The oncology test products are collectively classified as "In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product".

Following downgrade to Class II, future market submissions for these product categories may follow the 510(k) pathway, eliminating the need for large-scale clinical trials required for PMA. This will significantly shorten the market entry timeline and reduce compliance costs.

四、Practical Recommendations for Device Companies Entering the U.S. Market

Track classification updates of similar products to optimize market access strategy：If your device is of the same type and intended use as a recently downgraded device, you may submit a 510(k) clearance application under the new classification directly, instead of going through the PMA pathway, which will save considerable time and costs.

Accumulate clinical data and proactively file reclassification petitions：If your device has been on the market for years with sufficient safety and effectiveness data, and its current classification is significantly higher than its actual risk level, you may proactively submit a Section 513(e) or 513(f)(3) reclassification petition to the FDA. A successful petition will not only benefit your own product but also establish a first-mover advantage in the industry.

Prioritize De Novo feasibility assessment for innovative devices：For novel low-to-moderate risk devices with no existing predicate, you may directly assess the feasibility of the De Novo pathway, without first submitting a 510(k) and waiting for an NSE determination, to accelerate your product launch timeline.

五、Conclusion

Medical device regulation evolves dynamically alongside technological advancement and clinical evidence accumulation. Reclassification reflects the FDA’s refined risk-based regulation, and also presents important opportunities for companies to optimize their compliance strategies.Continuously tracking classification rule adjustments and planning market access pathways in advance is an essential practice for medical device compliance in the U.S. market. For further inquiries, welcome to consult Wiselink！

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