We have written in previous issues about how the U.S. Food and Drug Administration (FDA) allows products to get quick approval and how that system has been abused. Medical device makers can win quicker approval along the so-called 510(k) pathway for products deemed “substantially equivalent” to other devices. That is allowed even when their technology isn’t the same and it carries different risks and benefits. In draft guidance, the FDA outlined high-level policies as well as a number of hypothetical examples to illustrate how device manufacturers can pursue new technological approaches without having to go through the arduous approval process that surrounds devices that are viewed as truly distinctive.
The guidance could be used to allow devices that have the same basic purpose as previously cleared products, but have a “significant change in the materials, design, energy source or other features.” The FDA appears willing to accept some disparities in risks and benefits between similar products with different technological characteristics. The FDA gave this example:
• A device seeking streamlined approval along the 510(k) path might have greater risks but also greater benefits then a predecessor product and would therefore still qualify.
• Similarly, a device with less-pronounced benefits but also fewer side effects could also be found substantially equivalent.
The FDA said that it’s willing to consider applying a lower burden of proof on promising new technologies that look to be “important for public health.” In such situations, “We may accept greater uncertainty in an assessment of benefits and risks … in order to facilitate patient access to these innovative technologies,” the FDA said, cautioning that all determinations of substantial equivalence (SE), will be made on a case-by-case basis.
The guidance went into further detail in describing how the FDA will gauge risks and benefits. The amount of overall risk depends on the frequency, severity and duration of side effects, and similar considerations surround appraisals of benefits, the guidance said. Regulators also provided seven hypothetical scenarios to flesh out their thinking on when devices with new technologies will and won’t qualify for 510(k) approval. In one example, FDA officials described a new type of forceps that could expose additional anatomy to injury during spinal surgery but could also make operations faster, reducing the risks of infections and anesthesia-related complications. “This device would likely be found SE,” the guidance said.
Alternately, the FDA described the theoretical example of a tampon manufacturer that claimed to create a more comfortable product but also failed to convincingly demonstrate that its particular synthetic material would not increase the risk of bacterial growth associated with toxic shock syndrome. In such a situation, the product may not be similar enough to warrant 510(k) approval, the guidance said.
Based on our firm’s past litigation history with the manufacturers of drugs and medical devices, I am concerned that the medical-device manufacturers will abuse this approval process. If so, the health and safety of persons using their products could be put in serious jeopardy. There have definitely been significant abuses in the past and, for that reason, I hope Congress will change this law to better protect the public.
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