Office of Device Evaluation Director Donna-Bea Tillman will step down March 26 to join Microsoft's health unit, she said in a March 1 email to her staff.

Tillman, a biomedical engineer and 15-year ODE veteran, has led CDRH's pre-market review office since 2004. She will soon be the director of Regulations and Policy for Microsoft's Health Solutions Group, which develops health information technology products.

Christy Foreman, ODE's deputy director for Engineering and Science Review, will temporarily serve as office director while a permanent replacement is sought, the agency said.

Foreman, also a biomedical engineer, has been with CDRH since 1996. Hired as a device reviewer, she moved to the Office of Compliance in 2001 before transitioning back to ODE in 2008. She told "The Gray Sheet" that it is "not my intent at this time" to seek the ODE director post permanently.

The agency would not say whether its search will focus primarily on internal or external candidates.

External Pressures High, But No Sign Of Force Out

Tillman is largely well-liked by the device sector's regulatory affairs community, despite frustrations with what many in industry complain is an increasingly burdensome review process.

"Her knowledge of the science and the law, her desire to ensure new technologies were not delayed to the market by unnecessary data requirements and extended reviews, and her managerial skill will be missed by FDA and industry alike," said Mark Duval, a device law attorney. She was "often a ray of hope for industry," he said, when ODE reviewers were requesting, in Duval's view, extraneous data for pre-market submissions.

But pressure on Tillman's job has grown in recent years in response to complaints by lawmakers, patient advocates and some internal staff at ODE that the device review process has become too lenient and that device center management is too close to industry.

Tillman was harshly criticized in letters written to lawmakers and administration officials in 2008 and 2009 by a handful of anonymous ODE staffers. The letters suggested, among other charges, that she and her management team pressured reviewers to recommend approval or clearance for some devices against their scientific judgment (¹ Also see "CDRH Staffers To Obama: House Cleaning Urgent At Device Center" - Medtech Insight, 12 January, 2009.).

In particular, the letters alluded to strong disagreements between ODE/CDRH management and reviewers in the Radiological Devices Branch over approval of computer-aided detection devices for medical imaging. The tensions were likely one underlying factor in the recent transfer of the radiological branch from ODE to the Office of In Vitro Diagnostic Device Evaluation and Safety (² Also see "Radiology Devices Move To OIVD: More Cohesive Dx Reviews Ahead?" - Medtech Insight, 1 February, 2010.).

Tillman was also in the middle of the controversy that has developed around the December 2008 510(k) clearance of ReGen Biologics' Menaflex knee implant. Scrutiny of that clearance process has become a major catalyst for ongoing efforts to reform the 510(k) program (³ Also see "Internal FDA Menaflex Investigation Finds Serious Process Deviations" - Medtech Insight, 28 September, 2009.).

A ⁴ report issued last September by FDA following an internal agency investigation identified no evidence of Tillman inappropriately exerting pressure on staff to clear the device. She had determined the device to be "not substantially equivalent" to predicates over several rounds of the long-running Menaflex review process before changing her position in 2008 following an advisory panel meeting.

However, the report noted that "external pressures may have distorted" her decision-making process, and that her decisions also may have been impacted by her "sense of professional loyalty" to then-CDRH Director Dan Shultz.

Schultz resigned his position last summer after 15 years at CDRH (⁵ Also see "Schultz Exits: Pressures From Inside And Out Catch Up With CDRH Director" - Medtech Insight, 17 August, 2009.).

Schultz and Tillman joined the FDA device center the same year. She became a deputy director for ODE in 2003, when Schultz was director of the office. She took the helm of the review office when Schultz moved up to the CDRH directorship.

Tillman gave no sign in her email to staff March 1 that she was in any way pressured to step down. She expressed full confidence in the current device review process.

"One thing that gives me comfort is the knowledge that you all will continue to do the same great work that you have always done, so that the next time I am in need of a medical device, I can be confident in its safety and effectiveness," she wrote.

Tillman Has Consistently Focused On IT Issues

In the email, Tillman described a growing interest in the potential for health information technology to "improve health outcomes, and to help reduce the skyrocketing cost of health care."

The new job "will allow me to combine what I have learned during my years at FDA with my lifelong love for all things computer and my passion for public health," she said.

An interest in IT matters has pervaded her tenure at CDRH. Tillman was ODE's software coordinator in the late 1990s. And later, as director of ODE, she prioritized improving outdated systems to make the review process more electronic and less paper-based (⁶ Also see "Funding Limits Will Force Choices At Device Evaluation Office – Tillman" - Medtech Insight, 5 September, 2005.).

Tillman also has been active in developing CDRH's burgeoning policy for overseeing electronic health records. She chairs an ODE working group on the topic that formed in 2009 (⁷ Also see "FDA Probes Potential Overlap Between Electronic Health Records And Devices" - Medtech Insight, 30 March, 2009.).

Coincidentally, CDRH Director Jeffrey Shuren signaled last month at a Health and Human Services IT meeting plans for the center to increase its role in regulating electronic health records (⁸ Also see "Grassley Pushes, FDA Moves Toward Health IT Software Safety Oversight" - Medtech Insight, 1 March, 2010.).

Such an evolution will be central to Tillman's responsibilities at Microsoft, where she will be charged with ensuring that the firm's electronic health record systems and other health IT products comply with FDA and international regulations.

The Microsoft Health Solutions Group's highest-profile product is HealthVault , an online service for storing and sharing personal health records. The company has also developed IT systems targeting hospitals and other health care players.

- David Filmore ( ⁹ d.filmore@elsevier.com )

Tillman Departs: Device Evaluation Director To Leave FDA March 26

More from Archive

More from Medtech Insight