By Nick Otto
Two leg brace distributors recently filed lawsuits against the FDA, claiming that the agency improperly detained shipments of their devices after determining the products required premarket clearance.
The complaint was filed in U.S. District Court for the District of Columbia by Plymouth Direct Inc. and Nature’s Pillows Inc. In the filing, the plaintiffs claim that despite initially being told by the FDA that the BeActive leg brace didn’t require premarket clearance, the agency held shipments of the braces upon import. The FDA indicated that the device’s packaging suggests that it relieves pregnancy-related back pain, which would require that the device obtain 510(k) clearance.
In the filing, the companies said the agency’s decision to seize the shipments under the Federal Food, Drug and Cosmetic Act’s detention without physical examination (DWPE) is “arbitrary and capricious,” and that the FDA hasn’t “articulated any rationale” in supporting its conclusion that the initial determination that the braces didn’t require premarket clearance was incorrect.
When the suppliers submitted their draft labeling to the agency, the FDA said the device was considered a Class 1, 510(k)-exempt product, according to a recent blog post from Hyman, Phelps & McNamara, P.C. However, according to the complaint, between September and October of this year, the FDA detained seven shipments of the product via DWPE because the devices lacked 510(k) clearance.
“Products subject to DWPE will be detained at the U.S. border without being examined by FDA,” Registrar Corp notes. “The importer or exporter of the product must then prove to FDA that the shipment is compliant in order for the product to be released into the United States.”
According to the FDA, a DWPE will be recommended if there is evidence that shipments from an importer don’t follow legal regulation. Some examples the agency provides include:
- There is information received from other government agencies concerning violative practices by the importer or the importer’s foreign suppliers that would cause the articles to appear violative .
- There is a documented history of attempted importation of violative articles that has resulted in the issuance of a warning letter to the importer with no subsequent response from such importer or which does not result in the correction of such practice.
- There is verifiable information in the form of consumer or trade complaints, or otherwise, that has the effect of causing the articles offered for import to appear adulterated, misbranded, or otherwise in violation of the FD&C Act.
The BeActive brace is manufactured in China and supplied by the two companies in the U.S.