Device review changes at CDRH pose challenge for imaging vendors

Reform of the Food and Drug Administration's device evaluationprogram is finally taking shape after months of debate and speculation.The FDA clarified many of its most recent initiatives to speedup and simplify device review at a meeting last week with theheads of the agency's advisory committees. Full reform of thedevice review process could take years, however. That may be toolong for some small manufacturers with devices caught in the reviewbackup.

Most medical imaging manufacturers know first-hand of the ongoingproblems at the FDA's Center for Devices and Radiological Health.The center is underfunded, understaffed and frequently second-guessed.Device review decisions are often dissected and criticized bya gaggle of other regulators, legislators and interest groups(SCAN 3/10/93 and 9/23/92).

The result is a center that seems scared of its own shadow.Device reviewers leery of being hauled into congressional committeesto defend product review decisions have turned off the spigotof device approvals. This is one cause of a backlog of 510(k)and premarket approval (PMA) applications that has had disastrousconsequences for the medical device industry, according to JonathanS. Kahan of Hogan & Hartson, a Washington, DC, law firm thathelps manufacturers shepherd applications through the FDA.

"Small companies are going out of business or are layingoff people," Kahan said. "A lot of the larger companiesare exporting jobs and products to Europe and moving their facilitiesoverseas. It's been fairly devastating."

The average review time for a 510(k) application has doubled,from the traditional 90 days to 180 days, Kahan said. The numberof 510(k)s piled up at the agency has reached almost 4000, comparedto 1900 two years ago.

One foreign-based ultrasound company trying to crack the U.S.market has 510(k) submissions for several of its major productslanguishing at the FDA. One submission has been pending for over300 days, according to a company representative who requestedanonymity. The wait has resulted in lost revenues of over $1 milliona year, the spokesperson said.

"We've wasted a lot of marketing money going to tradeshows, thinking that (marketing clearance) was imminent and itreally wasn't," the spokesperson said.

Enter recently appointed CDRH director Bruce Burlington, whohas made his mark on the center with a raft of initiatives intendedto speed up and simplify device review. Since Burlington joinedCDRH in February, he has made clearing up the logjam a priority.

Some of the more significant reforms proposed for the CDRHinclude:

• fast-track review of life-saving medical devices;

• a communication process by which manufacturers candetermine the status of their 510(k) applications; and

• a refusal-to-file option for incomplete 510(k) applications.

The fast-track review option is intended for devices with potentiallylife-saving applications, although CDRH representatives said atthe June meeting with advisory committee heads that the fast-trackcriteria could be expanded to other devices as well. Expediteddevices would be moved to the top of a reviewer's stack of 510(k)and PMA submissions.

It's questionable whether many medical imaging devices willbe able to take advantage of the fast-track option, however. Indeed,some medical imaging device PMAs and 510(k)s could be delayedas expedited filings are sent to the head of the line.

More useful to medical imaging vendors should be the agency's510(k) status report system, which began operating last week.According to the FDA, the system allows manufacturers to determinewhich branch of the Office of Device Evaluation a device submissionhas been sent to, where a device stands in a reviewer's queue,and the center's most recent action on the application.

The third initiative is a 510(k) submission screening programthat gives the FDA the option of refusing to accept poorly assembledfilings. The FDA will screen each 510(k) filing as it comes in.If a filing lacks basic information, a letter and checklist willbe sent to the manufacturer to allow correction of deficiencies.If a 510(k) continues to have problems, the center can rate it"non-approvable" and return it.

While imaging vendors are ready to give the agency an "A"for effort, some fear its initiatives will be as effective asrearranging deck chairs on the Titanic. Until the FDA devotesmore funding to CDRH and signs on more device reviewers, the centerwill continue to be plagued by a backlog of submissions.

"I think they just have a head-count problem," saidBenjamin L. Holmes, vice president and general manager of Hewlett-PackardMedical Products Group of Andover, MA. "They need more resources.They talk about putting more reviewers in, but it doesn't seemthey are putting their money where their mouth is. The impressionis they are still adding people other than reviewers."

Increased resources are not likely to be forthcoming. WhileCDRH has been earmarked to receive a budget increase of $53 million,much of that money has already been claimed by existing programs,such as implementation of the Safe Medical Devices Act of 1990and the Mammography Quality Standards Act of 1992 (see story,page 2).

New sources of funds could come from device user fees similarto those assessed on the pharmaceutical industry. A proposal inPresident Clinton's budget to raise $200 million for the FDA throughuser fees was axed by the House of Representatives AppropriationsCommittee. Device industry groups such as the Health IndustryManufacturers Association, however, have begun to soften theiropposition to such fees. HIMA has indicated it would support userfees if they are used to speed up the device review process.

While Burlington's reforms continue, the turmoil at the CDRHcould last for the next two or three years. This could have seriousramifications for the device industry, according to Kahan.

"You're going to see lots of small companies not surviving,and their technologies will either be purchased by large companiesor they will go out of business and that technology will neverbe developed," Kahan said. "The large companies willbe extending their times for clearance for their products, andthe costs involved will increase exponentially for getting a productinto the marketplace."

How should imaging vendors handle their 510(k) and PMA submissionsuntil the situation is cleared up? In an address at HIMA's annualmeeting in March, Burlington said that for most devices, vendorswon't be required to conduct controlled clinical trials like thoserequired for pharmaceuticals. But submitting filings that containhigh-quality scientific data is one sure route to success fordevice applications.

"Good data in your application to FDA make our job mucheasier," Burlington said. "Good data clearly demonstratethe clinical benefit of your device, as well as identify the risks.Well-done trials on a carefully designed and manufactured devicecreate fewer questions and let us come to a conclusion quickly,not after three or four rounds of questions."

Good communication with the FDA also helps, according to ElaineK. Keeler, manager of clinical marketing and regulatory affairsfor Picker International of Cleveland.

"You have to talk to the FDA up front to find out whatthey are looking for, and make sure you provide them with thatinformation," Keeler said. "Take all the guidance thatis available and adhere to it. (Be sure) what you submit is clear,concise, well put together and meets the guidelines."