Submissions and Approvals

ARTICLES

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

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

FDA Issues Final Guidance on Direct Marking Requirements for UDIs

The FDA released final guidance on requirements for direct marking of devices with unique device identifiers. The final document closely resembles the draft version issued in June 2015. Read More

FDA Finalizes De Novo Evaluation Guidance, Proposes Acceptance Criteria

The FDA finalized guidance on the evaluation process for De Novo classification requests and issued draft guidance on the acceptance criteria. Read More

FDA Clarifies When New 510(k)s are Required for Device Updates

The FDA issued final guidance on when to submit a new 510(k) for a planned change to an existing device. Read More

FDA Approves First Pre-Calibrated Glucose Monitoring System

The FDA approved the first factory-calibrated personal continuous glucose monitor, manufactured by Abbott Diabetes Care. Read More

FDA Clears First Duodenoscope With Disposable Distal Cap

Following deadly superbug outbreaks linked to contaminated duodenoscopes, the FDA has cleared the first duodenoscope with a disposable distal cap to improve access for cleaning. Read More

Judge Dismisses Whistleblower Lawsuit Against Boston Scientific

A federal judge granted Boston Scientific’s motion to dismiss a 2011 lawsuit alleging False Claims Act violations related to the sale of certain models of its Cognis and Teligen defibrillators. Read More