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Michael Causey

FDA Compliance

RAPS Review: FDA CDRH Director Shuren Talks Priorities

The agency’s 2017 goals featured at regulatory professionals conference

Published: Monday, October 24, 2016 - 13:06

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San Jose, California. Shuren’s presentation was one of several sessions of particular interest to life sciences shops.

During his presentation, Shuren talked about the agency’s new strategy to use more real-world evidence to track the safety of medical devices. According to its Strategic Priorities Report for 2016–2017, the agency is developing a nationwide medical device evaluation system to more quickly identify safety signals, particularly through electronic health records, registries, and medical billing claims in which unique device identifiers are being used.

Meantime, while overall FDA enforcement is relatively flat domestically, it’s on the rise outside the United States. China remains the FDA’s top target, but there’s been some shift elsewhere around the globe with an increased focus on Canada, among other nations.

Canada feels FDA’s enforcement chill

But don’t get too worked up by that trend in the Great White North, says Nicole Landreville, a program manager for Regulatory Affairs with GE Healthcare in Toronto. It might be as simple as geography. “We’re so close and easier to get to,” she says, only half joking. She was the lead of a four-person team that conducted a two-day, standing-room-only regulatory pre-conference workshop during the RAPS conference. The session, “Regulatory Strategy Forum for Medical Devices,” was designed to help regulatory affairs (RA) personnel better understand their role when working with federal regulators—in any nation. Landreville’s workshop helped RA personnel navigate regulatory landscapes in a number of companies.

“Almost every firm wants to operate globally” and that means having to tangle with more regulators with more regulations, Landreville adds. She stresses that any regulatory compliance plans and documents mustn’t be static. Instead, they must be able to be revised and revisited almost constantly. That demands high-quality best practices and stringent control over electronic records.

“Regulatory affairs is a highly dynamic field that is in constant flux with global harmonization and the emergence of new technologies,” says Landreville. In addition to case studies, the workshop provided the serious RA professional with a comprehensive overview of regulatory topics that are of current importance in the medical devices industry.

A case study was dissected by teammates during a three-part working session where teams of six to eight members were assigned a fictional product and asked to build together a global regulatory strategy plan for selected global markets.

In addition to Landreville, the workshop faculty included three teachers with a total of more than 80 years of experience in RA:
• Brad Hossack, international vice president of regulatory affairs at Stryker Medical Corp.
• Patrick Lee, senior director of risk assessment and quality assurance at Vascular Dynamics
• Chitra Edwin, president of Biotechnology Consulting Solutions

Each of the faculty members brought a broad base of experience from many years in the industry and across many product lines.

CDRH sets sights on production controls

There were several other interesting tidbits gleaned from the CDRH report that Shuren discussed with RAPS attendees, including:
• Along with corrective and preventive actions (CAPAs), FDA warning letters for Production and Process Controls (P&PC) led the quality system inspectional observations. In 2015, inspectors reported 1,141 P&PCs and 1,131 CAPAs. CAPAs led in terms of actual warning letter citations with 111, followed closely by PP&C with 98, and DES at 68.
• Although the overall number of QS surveillance inspections fell last year, the FDA made nearly 10 percent more inspections outside the United States and promised that trend would continue for the foreseeable future. For the third year in a row, China, Germany, and Japan were the top three countries to receive FDA warning letters. However, as noted earlier, Canada and the United Kingdom broke into the top five in 2015, pushing Taiwan and Switzerland down the list.

First published Sept. 19, 2016, on the AssurX blog.


About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.