What it means for a device class to fall — from approval to notification, with regulatory weight set by risk
The Food and Drug Administration issued a final order reclassifying certain test systems used with approved cancer therapies from the strictest class III into class II. Premarket notification will suffice instead of premarket approval, with special controls established.
Document overview (primary data)
- Document typeRule
- AgencyDepartment of Health and Human Services
- Citation91 FR 53184
Key points
- The Food and Drug Administration reclassified certain test systems used with cancer therapies from class III into class II.
- Class III requires premarket approval; class II allows premarket notification under special controls.
- The subject is tests determining whether a patient should receive a particular cancer therapy.
- Special controls necessary to assure safety and effectiveness are established alongside the reclassification.
- Reclassification follows from knowing what controls are needed, not from a device having become safer.
1Regulatory weight set by risk
Medical devices are sorted into three classes by device type. The criterion is risk, and the higher the class the heavier the requirements before reaching market. A bandage and an artificial heart are not treated alike merely because both are devices.
| Class | What is required | Character |
|---|---|---|
| Class I | General controls | Basic requirements on labeling and manufacture |
| Class II | Special controls in addition to general controls | Premarket notification required |
| Class III | Premarket approval | Review of data showing safety and effectiveness |
Class III is the heaviest: a manufacturer must submit data on safety and effectiveness and obtain approval. Class II allows a premarket notification showing substantial equivalence to an existing comparable device. Dropping one class changes the path to market considerably.
2What was reclassified
- 1SubjectIn situ hybridization test systems used with approved cancer therapies
- 2PreviouslyClassified as class III, subject to premarket approval
- 3NowReclassified into class II, subject to premarket notification
- 4AlsoA new classification regulation and the necessary special controls are established
These are tests determining whether a patient should receive a particular cancer therapy. Because they are used together with the drug, an incorrect result can mean missing needed treatment or receiving one that will not work — which is why the risk was assessed as high.
3Why a class falls
Reclassification does not happen because a device became safer. It happens once enough is known about a device type to identify what controls will assure safety and effectiveness. That is why special controls are established at the same time the class falls: control through approval review is replaced by control through requirements settled in advance.
4A regime that can lighten itself
Regulation set heavy at the outset tends to stay heavy. The device regime holds procedures for revisiting classification as knowledge accumulates. This site separately covers work to classify accessories on their own risk rather than that of the parent device, showing the classification framework itself under continuous revision.
Why it matters
Graduating regulatory weight by risk, with procedures to revisit it as knowledge accumulates, is built into the regime. Moving from premarket approval to notification bears directly on the height of the barrier to entry.
FAQ
What are device classes?
Does a lower class mean no regulation?
Sources (primary)
Source: Federal Register (federal documents, public domain). Links go to the official site.