Devices & Diagnostics Letter

The FDA will likely see its budget reduced by $294 million if across-the-board cuts to federal programs go into effect on Jan. 2, 2013, as currently planned; the cuts are needed to comply with a congressional mandate to reduce the federal deficit.

The outlook for companies making implantable cardiac defibrillators (ICDs) may have just gotten a bit brighter, as the U.S. Department of Justice (DoJ) took a significant step toward closing out its investigation of off-label use of ICDs in U.S. hospitals.

Mobile medical apps that run on such consumer devices as smartphones and tablets represent a rapidly growing and lucrative device market for innovative companies that do their homework before diving in, an expert in the field says.

An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say.

Devicemakers seeking ISO 13485 certification can expect longer initial audits of their quality management systems (QMS), thanks to a new mandatory document by the International Accreditation Forum (IAF).

A California court’s decision to allow a case against Medtronic to go forward reaffirms that federal preemption does not apply in state liability cases alleging wrongdoing, legal experts say.

The final rule on implementation of the Physician Payments Sunshine Act continues to be held up by the Centers for Medicare & Medicaid Services (CMS), but the senators who coauthored the act will use a roundtable next week to mount more pressure on the agency.