Full article reprinted from "The Gray Sheet" - December 1, 2008
FDA's device center may be moving toward imposing more risk management measures on moderate-risk devices, on the model of recent statutory risk management authorities for drugs, industry lawyers observe.
Full article reprinted from "The Gray Sheet" - December 1, 2008
FDA's device center may be moving toward imposing more risk management measures on moderate-risk devices, on the model of recent statutory risk management authorities for drugs, industry lawyers observe.
On the drug and biologics side, Title IX of the FDA Amendments Act of 2007 gave FDA the authority to require sponsors to submit a Risk Evaluation and Mitigation Strategy (REMS) to manage a known or potential serious risk associated with a product.
So far, FDA has mandated REMS for 18 drugs and biologics, including about one-third of all new molecular entities approved since the statutory provisions took effect in March.
The developments have raised questions in the device space as to whether CDRH may also seek expanded risk management authority, lawyers from the Washington, D.C., firm Sidley Austin said during a Nov. 13 teleconference hosted by the firm and F-D-C Reports/Windhover Information.
The risk mitigation strategies for drugs can include a medication guide, a patient package insert, a communication plan, or elements to assure safe use, such as special training of health care providers or patient monitoring. FDA can require a firm to prepare a REMS if it decides one is needed to ensure that the benefits of the drug or biological product outweigh its risks.
CDRH Actions Reminiscent Of REMS, Lawyers Say
The Sidley Austin lawyers contend that CDRH has steadily been exercising "REMS-like" powers over more devices, even without express statutory authority. They point to CDRH public health notifications warning of risks associated with specific devices and recommending special physician training.
"If you look at the specific recommendations, it sounds like REMS-type language," said Sidley Austin associate Lauren Silvis.
Such voluntary recommendations may be a first step toward mandatory requirements, Sidley Austin partner Coleen Klasmeier told "The Gray Sheet."
"This pattern of public communications identifying a risk associated with a specific device, or category of devices, [is] similar to the pattern we saw on the drug side in the years leading up to the enactment of the REMS strategy provisions," Klasmeier said.
Asked whether CDRH might ever gravitate toward the REMS model, Susan Gardner, director of the Office of Surveillance and Biometrics, was circumspect. "As part of our post-market transformation, we continue to address improvements in our ability to assess product risk both pre- and post-market," she said.
FDA may begin pressing 510(k) sponsors to voluntarily adopt added risk management measures, the lawyers said. Device reviewers contacted one firm with a pending 510(k) and suggested that it establish a specialized training or certification program, according to Klasmeier.
"That starts to look more and more like the agency is considering asserting or seeking REMS-like powers," she said.
Expert: FDA Could Use Existing Authorities More
CDRH currently has the power to restrict the sale, distribution and use of PMA devices, for instance by making the device available only by prescription or by specifying practitioner training in the labeling, under separate sections of the Food, Drug and Cosmetic Act.
Requirements like physician training programs and post-market monitoring are standard features of the PMA approval for many implantable or life-sustaining products.
FDA can also impose restrictions on the use of certain 510(k) products through rulemaking, as it has done with hearing aids, but generally risk evaluation and mitigation strategies have not been part of the 510(k) clearance process, FDA says.
For 510(k) devices, CDRH has traditionally sought to mitigate risk largely through the Quality System Regulation's requirements for design control and corrective and preventive action plans, said FDA's Casper Uldriks, associate director for regulatory guidance and government affairs.
CDRH can also recommend special controls for certain 510(k) devices, including special labeling requirements, mandatory performance standards or post-market surveillance, though special controls do not carry the weight of mandated restrictions, notes Hyman, Phelps & McNamara lawyer Jeffrey Gibbs, formerly with FDA's chief counsel office. "They don't have the same clout."
Nevertheless, seeking new legislation to expand its post-market powers will not be a top priority for CDRH, predicted Gibbs.
"They do have substantial authority already," he said. "FDA has had a lot of latitude. Not REMS latitude, but they do have some latitude. They have just chosen not always to use it."
FDA could bolster its post-market powers without the need for new statutory authority by taking advantage of these existing authorities, said Gibbs, who does expect CDRH to incorporate some REMS concepts over time.
- Jessica Bylander
Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives.
