CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

Regulatory NewsRegulatory News | 17 September 2019 |  By 

The videos at 21st Century Scientific’s website show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency.

“Use on these terrains and functions that enable the device to lift the user, tilt the user, and bring the user to a standing position were not cleared,” the letter says, explaining that the original wheelchairs were cleared only “as a powered wheelchair to provide mobility to individuals restricted to the sitting position.”

Last year, the company told FDA that it did not submit a new 510(k) for its modified Bounder Powered Seating Systems because it concluded that these changes “do not add additional risk” based on a risk analysis and design validation and verification activities.

But FDA says that the firm did not provide any additional information supporting these claims about the lack of additional risks.

What’s more, 21st Century Scientific did not submit a medical device report (MDR) to FDA after receiving a complaint that suggests one of its powered wheelchairs may have caused or contributed to a broken arm, as detailed by a complaint from one of its users.

“There is no information in your firm’s complaint file to justify why the device would not be likely to cause or contribute to a reportable serious injury,” FDA adds. “Our inspection also revealed that you failed to adequately develop, maintain and implement written MDR procedures.”

Other Warning Letters

In addition to the CDRH letter, FDA’s Center for Drug Evaluation and Research sent a warning letter to Susan King-Harris, a Farmington Hills, Michigan-based podiatrist, for running a clinical trial without confirming participants’ eligibility before enrollment.

Harris told FDA that her overall noncompliance was due to a “lack of experience as a clinical investigator” and a “lack of exposure to the conduct of clinical trials.” But FDA said that response does not specify any corrective actions to prevent similar, future violations.

And FDA’s Division of Pharmaceutical Quality Operations II also released a warning letter Tuesday that was sent to Racine, Wisconsin-based antimicrobial hand soap manufacturer Deb USA after uncovering data manipulation, among other violations, at the company’s site.

“A torn-up HPLC chromatogram was discovered in a dumpster outside your facility on October 23, 2018. The chromatogram was for a stability testing assay result for Refresh PureBac Foam, lot 044262. The electronic file and method were manipulated yielding different results,” FDA said.

21st Century Scientific Inc

Susan P. King-Harris, D.P.M.

Deb USA Inc.


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