Author: Dan Sterling | Date: June 9, 2015
A better approach than limiting the FDAs scope along certain criteria through legislation would be to allow the FDA to be more nimble and empowered, with oversight to prevent regulatory abuse.
The 21st Century Cures Act is the talk of the medical device industry and Congress is moving quickly on it. What can passage of this law mean to medical device manufacturers? More importantly, what does it mean for those people reliant on medical devices for their well-being?
There are many good points in the legislation. And the aim of accelerating drug and medical device review times can provide medical device developers with faster time to market among other benefits. Indeed, Congressional involvement that advances any type of research and funding toward health care innovation is significant and laudable.
However, there are some possible unintended outcomes to consider. For example, the Act will require the FDA to accept or reject new standards within 60 days. This could put the FDA in a position of having to prioritize standard review and feedback over other important tasks, such as reviewing submissions – unless adequate funding is available to support this requirement.
The 21st Century Cures Act tries to create definitions for health software and then limit the FDAs authority to regulate them. Since the FDA has already published guidance on how they will restrain themselves in such cases, in the future, it will be easier to just revise guidance as technology changes, rather than to revise the law.
Passage of the 21st Century Cures Act in its current form could lead to dangerous consequences. When a law takes away FDA authority along certain criteria, some companies can find ways to develop software that should be treated as a medical device and slightly modify their claims in order to avoid regulation. When it comes to people’s health, the end result could be dangerous.
Imagine a situation where misleading or outright damaging software reaches the market, impacting thousands of lives. Do we want people to lose trust in medical software? Look at what’s happening in the herbal supplements industry. It is under intense scrutiny as more legislators and media outlets question the claims made by some herbal supplement manufacturers. For example, the New York Attorney General is investigating the multi-billion dollar industry*.
The truth is that technology companies which skirt the regulatory process can potentially create problems for viable medical device companies. Here’s why. Unreliable software that is perceived as a medical device, but which haven’t gone through the rigors of the FDA approval process, can cause mistrust among patients and doctors. What’s more, technology companies which bypass the costs associated with the FDA approval process gain an unfair financial advantage against medical device companies that follow the rules.
In a recent Legislative Hearing on 21st Century Cures, Dr. Janet Woodcock, Director of the Food and Drug Administration’s Center for Drug Evaluation and Research and Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health, presented key opportunities to speed up medical product development**. They include more emphasis on patient-centered development for medical products, inclusion of real-world evidence in review processes, and empowering the FDA to hire qualified experts, among other strategies.
Getting medical devices to market faster means that patients can get help sooner. The 21st Century Cures Act can help by providing resources to support the mission of the FDA. However, a better approach than limiting the FDAs scope along certain criteria through legislation would be to allow the FDA to be more nimble and empowered, with oversight to prevent regulatory abuse. The law should allow the FDA to continue to adapt, while applying common sense regulation to devices that could pose harm when used or misused.
As the details of the 21st Century Cures Act is deliberated, medical device manufacturers can continue to leverage proven processes, including implementing adequate testing and design controls, to help ensure their medical devices are safe and function as they are intended to in support of patient health.
* “Eric Schneiderman leads state attorneys general in push for ‘comprehensive inquiry’ into herbal supplement industry,” NY Daily News, April 2, 2015
** “Legislative Hearing on 21st Century Cures,” FDA, April 30, 2015
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