Submissions and Approvals


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

FDA Spells Out Which Microneedlers Are Medical Devices

Manufacturers of microneedling instruments that go beyond removal of dead skin cells should apply to the FDA for the first-ever marketing authorization of their products as medical devices, the agency says in draft guidance. Read More

App for Substance Abuse Treatment Wins FDA Marketing Clearance

The FDA approved marketing of a prescription smartphone app to help patients with substance abuse issues. The app, reSET, from Pear Therapeutics, is the first approved mobile medical application for treatment of substance use disorder. Read More

FDA Releases Final Guidance on Interoperable Devices

The FDA unveiled final recommendations for how medical devices should be designed to interact with other devices and IT systems. Read More

FDA Reports Uptick in Pediatric Device Approvals

The FDA approved a total of 71 premarket approval applications (PMA) and humanitarian device exemption (HDE) applications for pediatric use in 2016 — up from 61 approvals in 2015, the agency reported, in a newly released annual report to Congress. Read More

Singapore Launches Device Priority Reviews, Pre-Market Consultations

Singapore is introducing a pre-market consultation scheme and a priority review mechanism for medical devices. Read More

China’s High Court Pushes for Severe Penalties for Falsifying Device Clinical Trials

China’s high court called for severe criminal punishments for deliberately falsifying medical device clinical trial reports and other related documents,… Read More

Don’t Give Up on 510(k) Clearance Process for PreCert Pilot, FDA Says

Companies already seeking traditional 510(k) clearance for marketing digital health devices should not abandon that effort to switch to a new pre-certification program the FDA is piloting, the agency said. Read More

Pathways Can Shorten Devicemakers’ Road to Approval

Devicemakers looking to speed their products through the development process can get help from three lesser-known FDA pathways, according to two experts. Read More

TGA Proposes to Allow Marketing of Devices Approved Overseas

Australia’s Therapeutic Goods Administration is proposing to allow the marketing of devices that have already received marketing approval by certain overseas regulatory authorities. Read More