Recent FDA guidances cover software changes, real world evidence, wellness devices

By Jonah Comstock
04:12 pm

The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices. Lack of regulatory clarity is often cited as a force hampering innovation in digital health, so these moves by the FDA toward greater clarity are likely to be welcomed in many parts of the industry.

Read on for three recent guidances, and if that's not enough for you, check out our coverage of the FDA guidance on medical device maker data sharing that dropped back in June.

What? Deciding When to Submit a 510(k) for a Software Change to an Existing Device
When? August 8, 2016
Draft or Final? Draft

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This draft guidance would provide additional clarity for software manufacturers specifically about when a software modification requires a new 510(k) clearance. This is important in the case of medical apps, since app developers are accustomed to being able to regularly send out software and firmware updates to constantly iterate new products. It’s easier to do that when you have peace of mind about whether or not each update requires a new clearance. 

In the draft, FDA states that the key issue with the existing guidance on this “is that the phrase ‘could significantly affect the safety or effectiveness of the device’ and the use of the adjectives ‘major’ and ‘significant’ sometimes lead FDA and device manufacturers to different interpretations.”

To address this, the agency has provided a flowchart and a number of examples that illustrate how to use said flowchart. Developers will have 90 days from yesterday to comment on this draft guidance and express whether or not it provides sufficient clarity

What? Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
When? July 27, 2016
Draft or Final? Draft

This guideline is meant to update when and how companies can use data from real-world sources as opposed to structured, randomized trials as part of a device submission. This includes guidelines about when it’s appropriate to release a device without clearance as part of an investigational device exception (IDE) as Scanadu did with its home scanning device

Expanding acceptable data sources for establishing safety and efficacy has been an ongoing priority for the agency. In July Jeffrey Shuren, director of the Center for Devices and Radiological Health, and Commissioner of Food and Drugs Robert Califf penned a JAMA editorial on the topic.

The guidance outlines contexts where real-world data can be used, describes the requirements for acceptable data sources, and includes some examples of good use cases for real-world evidence.

What? General Wellness: Policy for Low Risk Devices
When? July 29, 2016
Draft or Final? Final

This is the big one. MobiHealthNews covered this policy in-depth back when it was a draft guidance, now it has been finalized with minimal changes. The guidance aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. 

The document outlines two different categories for general wellness devices that fall outside of FDA regulation. 

The first group of devices are those that "do not make any reference to diseases or conditions" and instead make claims that are more general. On their own, claims related to "weight management, physical fitness, including products intended for recreational use, relaxation or stress management, mental acuity, self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem), sleep management, or sexual function" are not going to move a device into a regulated category.

The second group of general wellness devices outlined by the FDA are those that do make reference to specific diseases or conditions, but only do so in two specific ways. They either claim to help users reduce the risk of certain diseases or conditions or they may help users better live with specific diseases or conditions.


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