Devices & Diagnostics Letter

Manufacturers should prepare for the possibility of extreme weather events by establishing a “safety stock” based on a site and product contingency plan, along with a disaster recovery program that defines inventory and back-up equipment, Sanofi advises in comments to the FDA.

A rare enforcement action against a mobile app developer for failing to get 510(k) clearance may have a positive effect by setting boundaries for the rest of the field, one mHealth expert says.

The U.S. Supreme Court has agreed to consider whether a licensee that is asking a court to issue a declaratory judgment absolving it of patent infringement must first prove its products don’t infringe the licensor’s patents, or whether the burden of proof falls on the patent holder.

An industry group has sued the Department of Health and Human Services, alleging that recent changes to federal orthotic and prosthetic payment rules shortchange providers.

Durable medical equipment suppliers were on the defensive during a Wednesday Senate subcommittee hearing on alleged improper marketing tactics targeting Medicare beneficiaries.

The FDA is hiring two new executives to restructure its Office of Information Technology (OIT) and address criticism by government auditors that efforts to integrate the agency’s vast IT system have taken far too long.

If the FDA implements standardized device labeling, it must allow for differences to account for the broad range of device types, users and environments, AdvaMed says.

The HHS Office of Inspector General is recommending Ohio’s state Medicaid agency begin using competitive bidding for some durable medical equipment (DME), after an audit found it could have saved about $3 million in one year.

Europe continues to cast a pall over the otherwise rosy picture presented by Medtronic’s fiscal 2013 fourth quarter results, analysts say in the wake of a Tuesday earnings call.

Electromedical Products International failed to reevaluate its supplier, per its written procedure, after finding high numbers of nonconformances in three lots of contract-manufactured devices, according to a recent FDA warning letter.

Weber Medical GmbH, a German manufacturer of laser therapy equipment, failed to follow its procedure requiring suppliers to have a quality management system in place, according to an FDA warning letter.

Riverpoint Medical failed to document and follow commitments for some of its corrective and preventive actions (CAPAs), resulting in a May 1 warning letter from the FDA.