US FDA official doesn't see device slowdown
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US regulators can target potential safety issues in medical devices without slowing down reviews of new products, according to a top Food and Drug Administration official.
US regulators can target potential safety issues in medical devices without slowing down reviews of new products, a top Food and Drug Administration official said on Thursday.
Recent problems with implanted devices such as heart defibrillators and drug-coated stents have placed the FDA under pressure to pay close attention to possible complications from new technologies, particularly after they reach the market.
Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said data gleaned from post-approval monitoring can help new products win approval more quickly, rather than delaying them as some companies fear.
"If we do this right and we can actually feed information back from the post-market surveillance process into the review process, we don't necessarily have to slow down the reviews," Schultz said in an interview with Reuters.
With closer tracking, "we can identify areas where it may be necessary to ask additional questions, but we can also identify areas where we've learned a lot and where we're not seeing problems," Schultz said.
Drug-coated stents have been dogged in recent years after reports that the tiny mesh tubes can cause rare but dangerous blood clots months later. Such stents include Johnson & Johnson's Cypher, Boston Scientific Corp's Taxus and Medtronic Inc's Endeavor. Abbott Laboratories Inc's Xience is awaiting FDA approval.
Implantable heart defibrillators, made by Medtronic, Boston Scientific and St Jude Medical Inc, took a hit following massive recalls from malfunctions.
Last week, FDA drugs chief Janet Woodcock told Reuters a new focus on safety was delaying approval of some medicines as the agency imposed new requirements to minimize side effects.
The FDA devices center has its own effort underway to improve post-approval monitoring of devices but has moved to make it easier for some devices to come to market.
Schultz cited, as an example, the FDA's recent reclassification of tissue adhesives and proposed reclassification of digital mammography equipment and some catheters used in angioplasty.
The devices are moving from a category that required the most information to win FDA approval for sale. Now, they will be in a middle category with less data needed for an agency review.
"Obviously everybody's concerned about safety and making sure that the products that are on the market are safe and have been adequately tested... I think we need to do more in that area," Schultz said.
But: "We also can't lose sight of the fact the new technologies going to the market are saving lives."






