File Closes on Document Leak: Final investigation leaves key questions unresolved.

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI May 1999 Column

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File Closes on Document Leak: Final investigation leaves key questions unresolved.

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI May 1999 Column

FDA is proposing a device reclassification that relies on data from PMAs approved at least six years ago. The use of such data is permitted in FDAMA section 216, which replaces a never-used provision from the 1990 Safe Medical Devices Act called the "four-of-a-kind" rule.

The four-of-a-kind rule allowed FDA to rely on data after four of the same kind of PMAs submitted after 1990 were approved. However, the rule was never really implemented, because agreement could not be reached on what "of the same kind" meant, according to CDRH scientific reviewer John Baxley. The current case represents the first time FDA will rely on this type of data, whose use is being proposed in the reclassification of extracorporeal shock-wave lithotripter devices from Class III to Class II (see the February 8, 1999, Federal Register).

Baxley sees this six-year-old-data provision as benefiting new PMAs for which a history of related approvals exists. For example, a new PMA candidate could do some sort of bench testing and feasibility testing (either animal or clinical testing), and then apprise FDA of the long history of use of the type of device.

FDA could then evaluate the bench testing and see whether the new device conforms to currently approved devices. If so, says Baxley, FDA could apply the knowledge on success rates, risks, and complications from the other PMAs to this new device. "This would speed review and approvals," he says.

Makers of already-marketed but unapproved devices for in vitro fertilization and other "assisted reproduction procedures" were in February given 60 days to submit 510(k)s for each device, to register their facilities and products, and to establish that they are in compliance with the QSR and all other regulations. Continued marketing is permitted until CDRH makes a "substantially equivalent" determination, but devices that do not qualify must be removed from the market pending approval of a PMA, according to the Center.

FDA says it is purchasing a Diasensor 1000 noninvasive blood glucose monitor from Biocontrol Technology Inc. (Pittsburgh) in order to "understand its behavior and the behavior of other types of remote sensing technology," according to FDA public affairs specialist Sharon Snider. Biocontrol failed at least twice to gain FDA clearance of its device in 1996.

The company says FDA will not use the monitor in the type of clinical investigation that would support market authorization, but rather to gain knowledge of the functioning of such devices over their full range of performance.

Scientific and engineering personnel from the company are to hold a seminar to educate agency staff on the use and maintenance of the device. A home-use instrument that eliminates the need for finger pricks, the Diasensor 1000 is not approved for sale in the Unites States but is being sold in the 15-nation European Union.

The Health Industry Manufacturers Association plans to work to see that FDA adopts a dispute resolution procedure that gives industry the opportunity to present its case in a scientific dispute to a third party who can "make a decision and come close to requiring the agency to adhere to that decision." HIMA executive vice president for technology and regulatory affairs James S. Benson says that something like binding arbitration is the kind of approach the organization would like to see.

"Such disputes only come up in a very small percentage of cases," Benson says, "but when they do hit, they can really hurt companies. There needs to be a clear-cut mechanism to address these disputes."

FDA has delegated responsibility for handling disputes to its centers, Benson says, and it is HIMA's understanding that a draft guidance will be issued shortly. "If that guidance meets our needs, that will be fine. But if it doesn't, we will be submitting comments and will consider whether we should approach some people in Congress to ask if they believe what the agency did was adequate."

Another HIMA initiative for 1999 is to establish a database on consensus standards that companies can meet and then file compliance reports to FDA in lieu of submitting test data. "There's a multitude of consensus standards out there," Benson said. "The idea of the database is to be able to improve communications by letting people know what standards are available and who they can talk to in various companies and organizations about standards they've used." Benson said the database could be maintained by a third party or kept on HIMA's Web site.

A series of meetings with CBER officials has also been undertaken with the goal of improving communications between industry and that center's regulators. "We've had very good meetings with some of the people who are regulating devices for CBER," Benson reports. "We've mapped out steps for improved communications. They are willing to set up vehicles to get a better handle on the review process. Since there are no user fees supporting device review, it often ends up on the bottom of the heap. We know CBER is trying to turn this situation around and get some management controls in place."

Benson notes that HIMA has "done the same kind of things on some issues with CDRH and it has worked very well. Good things happen when you are able to sit down around the table and work through issues."

In a joint advisory dated February 22 with CDC and OSHA, CDRH warned health practitioners of the risk of injury or infection due to accidental breakage of glass capillary (blood collection) tubes. The advisory—which follows the death from AIDS of a physician who contracted the disease from a broken tube—urges use of safer products, such as tubes not made of glass or those wrapped in puncture-resistant film.

Copyright ©1999 Medical Device & Diagnostic Industry

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