FDA Loosens Regulatory Controls on Stair-Climbing Wheelchairs

Posted 14 April 2014 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has decided to down-classify stair-climbing wheelchairs from class III to class II medical devices, meaning they will no longer require premarket approval.

Background

In the US, medical devices are classified according to risk. Class I medical devices represent the least risk to patients, and are often exempt from premarket regulatory oversight (so long as they meet FDA-defined standards).

Class III devices represent the opposite end of the spectrum, and are those thought or known to be the most dangerous to patients. Class III devices are usually (but not always) required to seek FDA approval through a premarket approval (PMA) process.

Then there are Class II medical devices, which represent a lower degree of risk compared to class III devices, but enough risk that FDA still wants to exercise some degree of premarket oversight over them. FDA does this by requiring Class II devices to adhere to both general controls (like Class I devices) and "special controls," which are basically standards meant to account for the specific risks of a class of similar devices. FDA also usually requires Class II devices to be "cleared"-not "approved"-through its premarket notification [510(k)] pathway which seeks to establish that a new device is "substantially equivalent" to an already-approved predicate, and is therefore suitable to be marketed without requiring new clinical trials. The equivalent device essentially relies on the predicate's findings of safety and efficacy.

New Classification

Historically, stair-climbing wheelchairs, which allow their users to ascend and descend stairs without the use of a ramp or elevator, have been classified as Class III medical devices owing to their potential risks. For example, if a wheelchair was unbalanced or otherwise faulty, it could result in the chair tipping over, sending the patient-often an elderly person-into a potentially lengthy (and possibly fatal) fall down the stairs.

Regulators have also noted concerns about potential entrapment, use error, device failure, pressure sores, bruising caused by jarring descents, burns or shocks caused by battery failures, and allergic reactions to materials used in the devices.

But FDA has been looking to reclassify these devices for quite some time. In December 2013, its Medical Devices Advisory Committee recommended that the devices be placed into Class II with special controls. FDA said it agreed with the panel's general recommendations, and last week issued an order that will see the devices classified as Class II devices subject to a variety of special controls.

The devices will be required to be cleared by FDA through the 510(k) pathway prior to being allowed on the market, FDA said.

Mitigation Measures for Stair-Climbing Wheelchair

Identified riskMitigation measures
InstabilityPerformance Testing.
Usability Testing.
Software Verification and Validation.
Design Characteristics.
Labeling.
EntrapmentPerformance Testing.
Usability Testing.
Software Verification and Validation.
Labeling.
Use ErrorUsability Testing.
Labeling.
Falls and Associated InjuriesPerformance Testing.
Usability Testing.
Labeling.
Battery/Electrical/Mechanical FailurePerformance Testing.
Electrical Safety Testing.
Software Verification and Validation.
Battery Testing.
Labeling.
Pressure SoresDesign Characteristics.
Usability Testing.
Labeling.
BruisingDesign Characteristics.
Usability Testing.
Labeling.
BurnsBattery Testing.
Flammability Testing.
Electrical Safety Testing.
Labeling.
Electrical shockBattery Testing.
Electrical Safety Testing.
Labeling.
Electromagnetic InterferenceElectromagnetic Compatibility Testing.
Labeling.
Adverse Tissue ReactionBiocompatibility Testing.


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