Wednesday, June 22, 2011

FDA's proposed changes in 510(k) process are still in their own process

By James M. Connolly

Some 10 months after the U.S. Food and Drug Administration announced plans to change the processes for 510(k) review and approval of many medical devices the industry is still waiting to see just what those changes will be.

“Actually a number of the plans were to be activated this year. I would be surprised if they get them all out before the end of the year,” said attorney Suzan Onel, a partner and chair of the food and drug practice at K&L Gates LLP. She noted that any proposed changes have to be circulated as drafts, and that substantive changes would require a process of notice and comments, but that some of the proposals have actually been sent out to the National Academy of Sciences Institute of Medicine (IOM) for more formal recommendations.

The FDA issued a report in August reviewing its own procedures, and recommended changes such as providing more information and clarification early in a product review process and addition of a new category of devices, so-called “2B” devices that in the past would not have required clinical data but now would need such data. Observers note that the report came in the wake of several years of turmoil at the FDA when there were claims of political interference, inconsistency in the review process and inexperience among reviewers.

Elements of the proposal, including the 2B category for certain devices, were shipped out to IOM, which was supposed to return with its own report in May, but is now expected to report in July.

The 510(k) process allows medical device developers to get market approval for lower-risk devices without the level of clinical data required of high-risk devices that go through a complete pre-market approval process.

“Our members are very concerned that the FDA is proposing drastic changes to a program that has served the patient and health-care delivery system for many years. While review of a 35-year-old program is to be applauded, some of the changes that they have proposed MassMedic members feel will stifle innovation,” said Tom Sommer, president of the industry group MassMEDIC.

Industry research has indicated that medical device companies are increasingly looking to overseas locations for their first device approvals, and that the FDA’s history of inconsistent reviews and more recent proposals are driving factors. This spring, The Boyd Co. Inc., a Princeton, N.J.-based research firm released a report that high operating costs in sections of the U.S. and the prospect of having to do more trials for the FDA have device makers looking overseas.

“Ultimately if this trend is to continue, our concern as health-care consumers is that the newest and most innovative technologies will be available outside the U.S. before they are available here,” Sommer said.

The irony with the 2B proposal is that it initially came out of the medical device industry, noted Onel. However, she said, the industry walked away from it when it appeared to be too cumbersome but that the FDA then took the lead on it.

She said another hot topic in the original FDA proposal apparently has been taken off the table by the FDA, at least for now. That was the plan to formalize the FDA’s ability to rescind a 510(k) approval. Last year, the FDA revoked the approval of a device after the agency decided that the product should not have been cleared in the first place. Attorneys have argued that FDA doesn’t have the authority to rescind 510(k) approvals, and that only Congress can give it that authority.

Onel said that one danger for the industry at large if the FDA did get the authority to rescind approvals is the domino effect on companies that cite those devices as predicate devices in their own submissions. Rescinding such a predicate device could then invalidate approvals for those subsequent devices, she said.

Both Sommer and Onel said that the aspects of the FDA proposals that the industry and legal community do support focus on ironing out the inconsistencies in the review process.

Onel endorsed the concept of more complete and clear guidance documents that define the type of information that a reviewer will be looking for. “Guidance documents, even though they aren’t laws or regulations, are helpful in understanding what the FDA is looking for. If you only find out about it when you are in the midst of a nasty interaction with the agency, it completely delays the clearance,” said Onel.

Sommer said that in addition to the need for guidance documents, the FDA proposal also calls for additional training for the FDA staff and more expertise among reviewers.