The Advanced Medical Technology Assn. released a study of the safety records of medical devices cleared for the market via the Food & Drug Administration’s 510(k) process.
AdvaMed, which represents the device industry, said its analysis of Class I recalls for 510(k)-cleared products shows that the process is "remarkably safe."
Less than 1 percent of devices cleared since 1998 were involved in Class I recalls, according to the study. Class I recalls involve products that could cause serious injury or death. The study, conducted by Cambridge, Mass.-based Battelle Memorial Institute, looked at the roughly 47,000 medical devices cleared through the 510(k) process during that period. The study also found that only 0.08 percent of cleared devices were recalled for design reasons that might have been detected during pre-market review.
“If you look at the data, you’ll see a situation where it’s hard to imagine any other regulatory process that will have as good a record at weeding out unsafe products before they reach patients,” AdvaMed vice president David Nexon said during a conference call discussing the study.
AdvaMed is wary of the 70-plus changes that the FDA is currently considering for the 510(k) process and said its analysis is evidence that additional pre-market review requirements are not likely to significantly increase device safety.
Recent internal evaluations by the federal watchdog agency have shown that the device industry is frustrated with the efficiency of the 510(k) process. The Center for Devices & Radiological Health received a record number of calls from the industry last year, according to a report from the FDA’s ombudsman. The CDRH saw a dramatic, 45 percent increase in complaints last year, logging a record high of 133 in 2009.
AdvaMed believes the FDA’s recommendations regarding increased reviewer training, development of additional guidance and greater communication of reviewer decision rationale could address the apparent deficiencies that result in delays and inconsistencies in the program.
"Reform of the 510(k) program is appropriate, but you need scalpel, not a meat axe," Nexon said, citing the AdvaMed study as reinforcement.
The FDA is gathering public input on its proposed changes to the 510(k) program through Oct. 4.