For Diana Zuckerman, last week’s open forum on the 510(k) process at the Center for Devices and Radiological Health felt a little like going one-on-400.
The president of the National Research Center for Women & Families told MassDevice she felt quite conspicuous as the lone public health voice in a room full of medical device industry advocates.
“I was pretty much it,” Zuckerman told us. “I think it was all industry, one patient and me and on the discussion panel it was industry plus FDA people and me.”
Zuckerman was a presenter and a panelist at the Feb. 18 public meeting convened by the Food & Drug Administration to discuss the 510(k) program, ahead of internal and external reviews of the process by which some 3,000 medical devices — the majority of the medical device clearance applications submitted to the FDA — are approved each year.
The program relies on so-called “predicate devices,” or products the agency has already cleared. Device makers must prove that their new device is an advancement on similar devices the agency has already cleared for market. Devices that are radically different must undergo the more rigorous, and expensive, PMA (pre-market approval) process.
Zuckerman, who has been a national voice on women’s public health issues for three decades, including stints as a U.S. Congressional Fellow and a senior policy advisor to then-first lady Hillary Rodham Clinton, said she felt the meeting fell a little short of a soul-searching examination.
“I was very surprised at the almost complete lack of concern expressed about any aspects of 510(k) other than the fact that it’s not fast enough,” she said. “It seemed like quite a consensus that it was better two years ago when it was quicker, but there was zero concern about any shortcomings in the process.”
Zuckerman said that data her organization has been collecting point to some serious public health concerns about the way the majority of medical devices are cleared. She said the National Research Center for Women & Families has been working on a study of medical device recalls, which they expect to release sometime in the next few months. There seemed to be a disconnect between public health and the attitudes she encountered at the meeting, she said.
“Public health has to be bottom-line here and I did not see one word expressed in terms of concern about public health, not one word,” she said. “It’s not like people in that room didn’t know that defibrillators didn’t work and people died. People in the room know it very well.”
Zuckerman added that she was surprised at differing attitudes between medical device company reps and their counterparts in the pharmaceutical industry, who she said will at least admit that some ineffective products can slip through the regulatory cracks.
“The device company people talk about how great their products are and how great the 510(k) process used to be until it got slower,” she said, adding that while she didn’t think the entire program needed to be scrapped, it does need a major overhaul. “The 510(k) program is based on substantial equivalence to a product approved before 1976. That whole concept seems very strange for an industry that seems to pride itself on being innovative.”
If she had her way, Zuckerman said implantable and life-saving devices would be disqualified from the 510(k) process, along with diagnostic tests to determine whether a patient suffers from a life-threatening illness. And while she’s hopeful that some of her words resonated with FDA officials present at the meeting, she conceded that her presence probably didn’t carry much water with many of the industry types.
“I don’t think I was perceived as much of a threat,” she said. “People didn’t seem upset by my comments. They seemed very confident in how great their products are. One might say they protest too much.”