Medical Device Recalls and the FDA Approval Process
The approval system for medical devices by the Food and Drug Administration has two tracks: Pre-Market Approval (PMA), which involves clinical trials and inspections; or, alternatively, the fast-track 510(k) approval, which only requires a device to be “substantially equivalent” to an existing one. Although the 510(k) process has come under criticism, the precise extent of the risks involved with “fast-tracking” medical device approval has not been studied comprehensively.
A 2011 study by the American Medical Association published in the Archives of Internal Medicine, “Medical Device Recalls and the FDA Approval Process,” examined the initial approval process for 113 devices that were then ultimately recalled by the FDA between 2005 and 2009 for posing serious health risks, including endangering patients’ lives.
The study’s findings include:
- Of the 113 devices recalled between 2005 and 2009 that the FDA determined could cause serious health problems or death, only 21 had been approved through the PMA process (19%). A further 80 (71%) were cleared through the fast-tracked 510(k) process, with an additional eight being exempt from any FDA regulation (7%).
- Devices related to cardiovascular health comprised 31% of the high-risk recalls. Of these, two-thirds were cleared by the 510(k) process.
- The cost of the PMA process is $870,000 per device, whereas the 510(k) process typically costs only $18,000. However, costs associated with recalls and health complications for millions of individual patients using these 113 devices were incalculably high.
The study’s authors conclude that reform of the FDA regulatory process is needed, as most of the dangerous devices recalled were first fast-tracked or were exempt from initial scrutiny.
Tags: safety, technology
Note to instructor: The suggested assignments are designed for flexibility. They can be used in whole or part and can be adapted to a particular task -- for example, the newswriting assignments could be applied to the writing of the headline, the lead, the nut graph or the full story. Material from the assignments could also be combined with other material, for example, in the writing of a background, feature or local-angle story.
Read the American Medical Association study "Medical Device Recalls and the FDA Approval Process."
- Summarize the study in fewer than 40 words.
- Express the study's key term(s) in language a lay audience can understand.
- Evaluate the study's limitations. (For example: Do the results conflict with those of other reliable studies? Are there weaknesses in the study's data or research design?)
Read the issue-related Los Angeles Times article "Despite recalls, medical device industry presses FDA to speed up approval process."
- If you were to rewrite the article based on knowledge of the study, what key changes would you make?
- Write a lead (or headline or nut graph) based on the study.
- Spend 60 minutes exploring the issue by accessing sources of information other than the study. Write a lead (or headline or nut graph) based on the study but informed by the new information. Does the new information significantly change what one would write based on the study alone?
- Interview two sources with a stake in or knowledge of the issue. Be prepared to provide them with a short summary of the study in order to get their response to it. Write a 400-word article about the study incorporating material from the interviews.
- Spend additional time exploring the issue and then write a 1,200-word background article, focusing on major aspects of the issue.