Steve Baker: The FDA’s Glacial Pace

The FDA’s draft guidance on radio-frequency wireless technology hasn’t made much of an impact. Why? Because no one knows if the guidance will ever move out of draft stage.

The draft guidance has aged five years since its initial publication for comments on Jan. 3, 2007. What’s the deal? The FDA author, who certainly knows his material, wrote a guidance document and many medical device manufacturers responded to the request for comments within the 90-day deadline. Consider also the new draft guidance from the FDA on mobile medical applications, issued July 21, 2011. The incentive to respond is reduced when it is unlikely to leave draft status within a relevant time-frame. Ironically, the FDA web page for both documents states: “This draft guidance when finalized will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.” [Emphasis added.]

Great, but when will they be finalized, and how current can the thinking be if the draft and comments are more than 5 years old? Ironically, the FDA approved and released the medical device data system (MDDS) ruling within two years of the initial draft. It has been widely viewed as needing another comment period due to the confusion in the healthcare industry. Maybe the FDA just can’t win?

I applaud the FDA for releasing the draft documents on radio-frequency wireless technology and mobile medical applications, but consider how the world has changed since early 2007. Maxwell’s equations on electromagnetic theory haven’t changed, but the smartphone debuted, many wireless devices now compete for bandwidth, and wirelessly enabled medical devices are popping up everywhere. The Apple iStore and Android have several thousand healthcare applications available for download, and hardware healthcare-specific add-ons are available. As the number of hospitals using Wi-Fi grows, the focus on the benefits and challenges of wireless medical devices and applications increases as well. Hospitals that formerly banned cellular phones now install cellular microcells for better indoor coverage.  We now have IEEE 802.11n running at hundreds of megabits per second. Virtually every cellular handset and PC has Bluetooth (BT) and Wi-Fi standard and you can now purchase BT-enabled heart rate monitors and glucometers.

The draft guidance on wireless technology becomes less relevant with each advance in the technology. We are hopeful for an update that addresses the unique challenges of today’s wireless landscape to complement the draft on mobile applications. Dealing with software based products that are agile and enable fast product lifecycles is a challenge that impacts all players—from device manufacturers to healthcare delivery organizations to standards bodies. Adapting regulatory processes to support fast-evolving product development is important to support innovation while maintaining safe and effective medical devices.

The FDA is not immune to this acceleration in technology evolution and having draft guidance documents languish in limbo is not a recipe for adaptation. Will the FDA continue with the slow pace that we have come to expect from our leaders in Washington, or will it adapt and adjust in a more nimble manner that allows for proactive vs. reactive response?

Steve Baker, PhD

Principal Engineer

Welch Allyn

2 thoughts on “Steve Baker: The FDA’s Glacial Pace

  1. The biggest issue here is that the medical community and with that the FDA simply cannot move fast enough. It is the accelerated technology evolution as Steve has said. Even if it did move out of DRAFT stage it would have no relevance to the marketplace.

  2. There are actually numerous FDA draft guidelines and proposed rules on various subjects, many whose age can be measured in multiple years. Possible reasons for this are (1) shifting priortities and resources, (2) distraction, (3) champions have retired/moved on, (4) newer drafts from the current leaders are fundamentally more exciting than older drafts from former leaders, (5) it was just put out there to stir the pot, (6) drafts generate a degree of expectation since a guidance document isn’t mandatory anyway, (7) moving to final is hard work…and no doubt others.

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