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Editor’s Picks: Notable Gray Sheet Stories From 2013

This article was originally published in The Gray Sheet

Executive Summary

2013 was a challenging year on some fronts for industry, and the impasses in Congress did not help. But there were some positive policy signals from FDA. There were also some very significant rules finalized – for the unique device identification and the Physician Payment Sunshine Act programs – that signal the need for important implementation efforts in 2014. Here are some of last year’s most important stories from “The Gray Sheet,” based on web hits and editor prerogative.

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CDRH Preps New Program To Streamline Approval-To-Reimbursement Path

The device center is in the very early stages of launching the “CDRH Reimbursement Program,” planning to go beyond its current parallel-review collaboration with CMS to work with device firms, CMS and private payers to streamline the pathway from market approval to reimbursement.

Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up

After the two-week shutdown, FDA staff are facing a backlog of fiscal year 2014 device submissions. The agency says it is working on a plan and assessing its ability to meet its MDUFA III commitments. The bigger concern, however, may be the regulatory uncertainty created by the short-term deal in Congress.

FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance

In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.

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