• E-mail
• Print
• RSS

Shelhigh and FDA settle

Device Regulation Alert: Safety, Compliance and Reimbursement News, July 2, 2007

The FDA and Shelhigh, Inc. announced a settlement of FDA claims concerning its implantable devices. Click here to read the May report in the Device Regulation Alert.

Under the consent order entered June 22, Shelhigh must address manufacturing practices and take action to bring seized medical devices into compliance with FDA standards.

The consent order addresses the conditions to release for seized devices. It requires Shelhigh develop an FDA-approved plan to recondition the seized devices. The company must also get independent experts to inspect the company for compliance with current good manufacturing processes and medical device reporting requirements. Those independent experts will report to the FDA and the FDA may also conduct its own inspections as well.

Shelreferred to the resolution in a June 25 press release as a "no-fault settlement agreement" emphasizing that the FDA did not require a recall and no recall is being made by Shelhigh. The consent order recognizes that Shelhigh does not admit the violations the FDA alleged in its complaint against Shelhigh.

• E-mail to a Colleague
• Print
• RSS
• Archive