FDA in recent months has been going the extra mile to aid Medtronic PLCin its regulatory development of a next-generation insulin pump-glucose monitor system, according to a company official

That has meant monthly, in-person meetings where agency officials provide detailed feedback on the company’s clinical plan, explains Patricia Shrader, Medtronic’s VP, Corporate Regulatory and External Affairs. Such regular meetings go well beyond standard company-FDA interactions for premarket submissions.

“Our original goal was 2020 to get this product on the U.S. market, but FDA’s goal is 2015,” Shrader said April 23 at the Food and Drug Law Institute’s annual meeting in Washington, D.C. The investigational product is Medtronic’s MiniMed 640G insulin pump, featuring predictive low-glucose management technology, and it’s one that FDA has “a great deal of interest” in seeing put on the market, the Medtronic executive said.

The agency has set up monthly meetings of several hours duration with Medtronic to answers questions and provide guidance on the best regulatory pathway for the product, for both premarket and for postmarket monitoring, Shrader explained at the meeting.

During the meetings, Medtronic describes to CDRH planned trials for the new product, Shrader told the FDLI crowd. FDA reviewers in turn provide feedback on the trials, or in some cases, explain to Medtronic which data the company does not have to supply, or steps that can be skipped to hasten regulatory approval, she explained to “The Gray Sheet” following her FDLI panel session.

“What this interactive process does is provide us clarity as to what they want,” Shrader said.

MiniMed 640G is intended as a step up from Medtronic’s recently approved MiniMed 530G low-glucose-suspend system. (See Also see "Medtronic Sees Long-Awaited Approval Of MiniMed 530G As A Big Step In Artificial Pancreas “Journey”" - Medtech Insight, 7 October, 2013..) The 530G was approved to automatically stop insulin delivery when continuously monitored glucose values drop to a pre-set level and the patient does not respond to the “threshold suspend” alarm. The next-generation device is designed to predict when a patient is headed toward hypoglycemia about a half-hour before they reach that point, and suspend insulin delivery in advance.

Broader CDRH Focus On Early Collaboration

FDA’s outsized effort in this case fits with the agency’s long-stated priority, pushed by patient advocates and others, to accelerate development of a fully closed loop artificial pancreas. (See Also see "Artificial Pancreas Guidance Allows For More Flexibility In Trial Design" - Medtech Insight, 19 November, 2012..)

But the early and extensive interaction with Medtronic appears to dovetail with a broader focus by the device center for potential breakthrough products. In that direction, earlier this week, FDA issued a draft guidance for its proposed Expedited Access PMA (EAP) program. (See Also see "Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway" - Medtech Insight, 22 April, 2014..)

Under EAP, FDA will select certain investigational devices for more intensive, early focus by its staff to help the manufacturer put together a feasible data development plan. The goal is to allow companies to complete lighter premarket requirements than usual if the device is badly needed by patients and sufficient postmarket controls can be established. CDRH Director Jeffrey Shuren estimates that, to start, about six devices per year on average might qualify for the EAP treatment.

Medtronic Gets Extra FDA Attention To Hasten Approval Of Next-Gen Insulin Pump

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