FDA to Review 510(k) Clearance Process for Medical Devices

WASHINGTON — For manufacturers who rely on FDA approvals
for their livelihood, clarity is a priceless commodity. New FDA
Chief Jeffrey Shuren believes the device approval process is ripe
for review, and he hopes to illuminate the premarket notification,
or 510(k) process, during a public meeting Feb. 18.

In a press release, Shuren pointed out that it has been more
than three decades since the agency established the current rules
that govern the clearance process for medical devices. “We are
looking forward to hearing from the public on issues related to
this program to help us improve it,” Shuren said.

According to the release, the FDA receives more than 3,000
510(k) submissions each year. Under the process, device
manufacturers must show that their new device is “substantially
equivalent” to a device already legally on the market that does not
require a premarket approval.

Ron Richard, CEO of San Diego-based SeQual Technologies, said
the FDA is planning to add hundreds of new reviewers this year to
unclog some of the bottlenecks at the agency. If the meeting can
add some clarity to such issues as how “predicate” devices
(previously cleared devices that may support a manufacturer’s
claim) are viewed, Richard believes the time will be well
spent.

“Manufacturers want to know what the rules are and how we are
supposed to engage and work with the FDA,” said Richard. “Any
manufacturer in the medical field is going to be looking for the
FDA to disclose to us what they need and what they want. If there
are going to be changes to the premarket approval process, clearly
define what those changes are going to be, and take as many grey
areas out as possible.”

The FDA classifies medical devices in three categories according
to their level of risk. Class III devices, including heart valves
and intraocular lenses, have the highest level of risk and
generally require premarket approval to support their safety and
effectiveness before they can be marketed.

Class I and Class II devices pose lower risks and include
devices such as adhesive bandages and wheelchairs. Most Class II
devices and some Class I devices can only be marketed after the FDA
has found them to be substantially equivalent to legally marketed
devices that don’t require premarket approval. Devices that are not
found to be substantially equivalent to a legally marketed device
require premarket approval.

“The FDA is covering a lot of ground now, and probably people in
the organization have been told to use a lot more scrutiny,
particularly when companies are filing for medical devices under
Class I, II or III,” said Richard. “The industry is really
compliant and forthcoming, and gives the FDA typically more than
what they want.”

The FDA also has asked the Institute of Medicine to conduct a
comprehensive study of the clearance process, but that study is not
expected to conclude until March 2011.

The Feb. 18 meeting will run from 8 a.m. to 5:30 p.m. at the
Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md.
Those interested in attending must register online (select the appropriate meeting
from the list) by Feb. 12. Written or electronic comments must be
submitted by March 5.

The meeting will be Webcast live at http://www.connectlive.com/events/fda021810.