Editor’s Picks: Notable Gray Sheet Stories From 2013

Article preview from "The Gray Sheet"- January 2, 2014

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.

Editor’s Picks: Notable Gray Sheet Stories From 2013

Article preview from "The Gray Sheet"- January 2, 2014

 

Shutdown Realities At FDA: No New Submission Reviews And More(Oct. 7)

Fiscal uncertainty for federal agencies is nothing new, but the floor just about dropped out in 2013. This had important implications for an industry so reliant on FDA approval to market its products. First, in March, the budget sequestration on appropriated funds and industry user fees took hold, restraining some of FDA’s activities. (See "Shuren To Lawmakers: Sequestration Is “Killing Us”" — "The Gray Sheet," Nov. 15, 2013.) Things really fell apart six months later when the government shut down for 16 days after Congress couldn’t agree on federal appropriations. FDA’s device center made efforts to continue reviewing submissions already in the works during that period, but it was unable to accept any new submissions for review, and was barred from other activities as well.

FDA Issues UDI Final Rule, Removes Direct Marking Requirement For Implants

Only rarely does an FDA edict affect the operations of virtually every device manufacturer as profoundly as the unique device identification rule. Issued last September, the regulation requires companies to create a unique identifier for each and every device they market, and to submit related information to FDA’s new global UDI database. Not surprisingly, manufacturers were especially energetic in trying to shape the final rule into a form they could live with.

CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role

While companies certainly continue to experience frustrations with FDA efficiency and predictability, there has been a palpable warming of overall industry-agency relations in recent years. One likely factor in that dynamic is the device center’s effort to solicit new ideas from outside innovators and use the input to rethink its programs. In particular, such efforts have come out of CDRH’s entrepreneurs-in-residence program, launched in 2011 with help from the White House.

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