Construction of CDRH’s new facility was recently completed, and now the entire staff is ready to move in. The address of FDA’s White Oak campus in Silver Spring is below:
10903 New Hampshire Ave., Silver Spring, MD 20993
CDRH began the move two months ago, and all staff should be located at the new campus by August 3, 2009. The center recommends that people reach staff members via e-mail because all office addresses, as well as phone and fax numbers, will change. If you can’t reach someone and you have questions, contact the center’s industry assistance staff:
E-mail: Â DSMICA@fda.hhs.gov
Phone:Â 800/638-2041
International: Â 301/796-7100
Fax: Â 301/847-8149
Construction on CDRH’s new facility in Silver Spring, MD, has been completed three months early. It marks the third building completed at FDA’s Silver Spring campus in the past five years (the other two: the $89.2 million, 573,261-sq-ft CDER building and the $42 million, 123,000-sq-ft central shared use facility).
The $93.7 million, 393,000-sq-ft, six-story CDRH facility has an exterior made of brick, cast stone, and curtain wall. Employees can use steel pedestrian bridges on the second and third floors for access to the adjacent laboratory facilities. A six-story atrium than stretches the length of the building is the new facility’s centerpiece. The new digs also include high-density storage space and a 150-person conference center.
CDRH’s Daniel Schultz told attendees at the Medical Device Manufacturers Association annual meeting that FDA and industry have not done a very good job of communicating to the public that the 510(k) process is not the “mindless rubberstamp that some people are making it out to be.†You can read more about his comments in Jim Dickinson’s Washington Wrap-Up column in the August issue of MD&DI. But below are some excerpts that may not make it into the print issue.
During the question and answer period at the meeting, Schultz was asked to comment on sponsors’ perception that the advisory committee process isn’t always as predictable as planned because of panel members asking questions outside the scope of the meeting’s agenda. “We try to be selective on what we take to panel,†he responded. “We try to take devices where we have specific questions that we want [OEMs] to address as opposed to taking every PMA to panel and no 510(k)s for instance.†That approach may change. Schultz said that the focus should be on what the question is and on the type of expertise necessary to make the best decision. “So I think maybe we’ll see a more risk-based approach to making those decisions.â€
In terms of predictability, Schultz said one of the issues CDRH needs to focus on is making sure the right expertise is represented on the panels. Conflict-of-interest issues make that challenging, he added, because a particular discipline may be very narrow. There may be only a few experts and they may all be conflicted, resulting in “having people [on the panel] who really don’t understand the particular issue or technology, giving you a variety of opinions that may not be exactly on point.†Schultz said that in terms of transparency, there will be more panel meetings, and the advisory panels have a valuable role to play there. He added, “then it becomes a matter of figuring out how to use the system as well as we can possibly use it.
“We can’t tell the panel members what to say, so obviously they have the right to ask the questions that they see fit,†Schultz said. “We can provide training for them to understand the regulatory questions we are seeking answers to, and we can focus the questions” in such a way that the panelists will help get FDA the answers it needs.
