North America

ARTICLES

IV Bag Shortage Continues After Hurricane Maria Damage

The FDA continues to grapple with shortages of saline intravenous injection bags that were worsened when Hurricane Maria devastated Puerto Rico, and the agency is temporarily allowing the importation of bags to boost the supply, Commissioner Scott Gottlieb said. Read More

How to Avoid Common CAPA Pitfalls

FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them. Read More

Jury Returns Verdict in Defective J&J Hip Implants Case

A federal court jury in Texas returned a $247 million verdict on behalf of six individuals who said they suffered serious medical complications from metal-on-metal Pinnacle Acetabular Cup System hip implants made by the Johnson & Johnson subsidiary DePuy Orthopaedics. Read More

FDA Raps ADB Interests for Lack of CAPA, MDR Procedures

The FDA faulted ADB Interests for its MDR, complaint-handling and CAPA procedures. Read More

First Telehealth Feature for Cochlear Implants Snags FDA Approval

The FDA approved a remote programming feature for Cochlear Americas’ Nucleus Cochlear Implant System — the first telehealth option for remote adjustments to cochlear implants. Read More

FDA Says Osteotech Must Improve Aseptic Processing, Investigations

The FDA cited Osteotech over inadequate sanitation and product deviation investigations. Read More

House Sets Deadline for HHS to Develop Bill of Materials Action Plan

The House Energy and Commerce Committee is giving the Department of Health and Human Services until no later than Dec. 15 to come up with an action plan for creating “bills of materials” to enhance cybersecurity for healthcare technologies. Read More

Bill on Use of New Medical Devices for Soldiers Heads to White House

The Senate gave final congressional approval to a bill designed to resolve a dispute involving the FDA and the Department of Defense, preserving the FDA’s authority over authorizing innovative medical devices for soldiers while streamlining the authorization process. Read More

Pioneering Digital Pill Receives FDA Approval

The FDA granted its first-ever approval to a prescription pill containing a sensor that verifies ingestion via electronic detection. Read More

FDA Unveils 3-Tiered Approach to NGS Oncology Testing

The FDA is taking a three-tiered approach to next-generation sequencing oncology with a newly approved tumor profiling assay, the accreditation of the New York Department of Health as an FDA third-party reviewer, and the creation of the Class II regulatory pathway for these devices. Read More