CDRH Pursuing Several Initiatives Affecting Medical Devices, Official Says

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By Bebe Raupe  


CINCINNATI--The Food and Drug Administration will advance several initiatives affecting medical devices by the end of this year, an agency official said May 2.

Christy Foreman, director of the Office of Device Evaluation (ODE) within FDA's Center for Devices and Radiological Health (CDRH), told the “MedCon 2013” conference that “it's busy year” as elements of the Medical Device User Fee Amendments of 2012 (MDUFA) are implemented.

Strengthening Premarket Review

MDUFA is a way to strengthen the premarket review process and break down barriers to approval, Foreman told the annual medical device conference held at Xavier University.

By Sept. 30, CDRH will take steps to modernize the approval system for new products and streamline the clinical trial process, she said via video link.

An “entrepreneur in residence” at FDA has been examining the process, identifying ways the agency can partner with industry to make the process more efficient, Foreman said, adding CDRH will be issuing pertinent recommendations soon.

Labeling, Personalized Medicine Goals

One of her office's goals this year is to improve the accessibility and usefulness of device labeling, Foreman said.

CDRH will assess device user needs to determine the adequacy of current labeling practices and initiate a discussion about content and format of device labeling by June 30, she said.

The center will propose initiatives to improve consistency, usefulness, and accessibility of labeling for home use devices by Sept. 30, she said, and take steps to incorporate the use of social media into CDRH communication processes.

Another CDRH goal, Foreman said, is to advance adoption of “connected health care.”

With this in mind, Foreman said CDRH will advance innovative solutions and technology by Sept. 30, aiming to strengthen and streamline the regulatory pathway from product concept to patient access.

In addition, Foreman said the center will move its “Personalized Medicine Program” forward; by Sept. 30, CDRH will take steps to enhance the field of personalized medicine by defining the appropriate regulatory paths for novel diagnostic devices and those that are intrinsically tied to a therapeutic purpose.

ODE was reorganized last November, with a division of surgical devices and division of neurological and physical medicine devices, Foreman said, with 12 new branches created across all seven review divisions in an effort to optimize efficiency and provide industry with “more consistent advice.“

Answering a question from the audience, Foreman said that under the Food and Drug Administration Safety and Innovation Act (FDASIA), the agency cannot disapprove clinical trial studies done overseas, and in 2012 the agency approved 80 percent of the 510(k) applications where the overseas testing was substantially equivalent to U.S. requirements.

Database Can Aid Device Design

Gina Brackett, a compliance officer with FDA's Cincinnati district office and co-chair of the conference, said the agency's “total product life cycle” database is an invaluable resource for medical device companies, particularly small and medium-sized firms.

The information can assist companies in product development by giving them insight into problems that have cropped up for similar devices, as well as steps taken to solve them, said Brackett, adding “hopefully you would use this information in premarket design and postmarket monitoring.”

She suggested device designers do “a deep dive” into a similar product's postmarket complaints with an eye toward mitigating any recall risk in their own design.

While Brackett said FDA is working on making the website simpler to use, “the data is there” in individual adverse event reports, she said. To ease searching, Brackett suggested looking by the name of a product rather than its code, which can include device accessories.

More than 350 medical device professionals attended this year's “MedCon” medical device conference, co-sponsored by the FDA and Xavier University.


Slides presented by Foreman are available at

The FDA product life cycle database is available at

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