FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

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Introduction
Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s commitment in the Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT Report to balance the need for active medical device oversight against the safety profile of the device. Collectively, the guidances demonstrate FDA’s continued intention to focus its resources on higher risk technology products. While welcomed news for many, an assessment of where any particular device may fall will continue to require close review and analysis.

We briefly summarize below the following four guidances:

  • General Wellness: Policy for Low Risk Devices (Draft Guidance) (January 20, 2015) [1]
  • Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (Draft Guidance) (January 20, 2015) [2]
  • Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Final Guidance) (February 9, 2015) [3]
  • Mobile Medical Applications (Final Guidance) (February 9, 2015) [4]

General Wellness: Policy for Low Risk Devices (Draft Guidance)
On January 20, 2015, FDA’s Center for Devices and Radiological Health (“CDRH”) issued a draft guidance providing its current thinking on its compliance policy for low risk products that promote a healthy lifestyle (described in the guidance as “general wellness products”). According to the draft guidance, FDA does not intend to apply its limited resources in examining low risk general wellness products to determine whether they are devices within the meaning of the Federal Food, Drug and Cosmetic Act (the “FDCA”) or, if they are devices, whether they comply with the applicable regulatory requirements including registration, listing, premarket notification, labeling, good manufacturing practice, and medical device reporting. The draft guidance defines general wellness products as products that meet two criteria: (1) the product is intended only for general wellness use (as defined by the guidance) and (2) the product presents a very low risk to the safety of its user. For the product to have a general wellness use, the product must have either an intended use that relates to maintaining or encouraging a healthy lifestyle or one that connects the role of a healthy lifestyle to reducing the risk or impact of certain chronic illnesses. According to the draft guidance, the general wellness policy does not extend to devices that are invasive, involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, raise novel questions of usability, or raise questions of biocompatibility.

This is a very interesting guidance and may provide significant relief for devices that meet the general wellness product definition. However, as industry and FDA move forward with trying to implement this draft guidance, we anticipate significant uncertainty due to the lack of clarity surrounding the terms “general wellness use” and “very low risk to the safety of the user.” Comments on this guidance are being accepted through April 20, 2015.

Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (Draft Guidance)
On January 20, 2015, FDA issued a draft guidance on medical device accessories. Typically, a device accessory is regulated either under its own classification (if a regulation has been issued for it) or under the same classification as its parent device (e.g., Class I, II, or III). Historically, this approach has posed difficulties for device accessories with lower risk profiles than their parent device because they were nevertheless included in the same regulatory classification as the parent. FDA’s draft guidance formally acknowledges this dichotomy and specifically states its intention to apply a risk-based approach to the classification of device accessories. 

The draft guidance begins well by providing a definition of “accessory” and “parent device” and describing its classification policy as applied to device accessories. FDA defines an accessory as “a device that is intended to support, supplement, and/or augment the performance of one or more parent devices.” [5] It defines a parent device as “a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.” [6] However, the draft guidance falls short in advising companies how to proceed since the only pathway discussed is the de novo classification process under FDCA 513(f)(2), which only applies to new low risk devices that have no legally marketed predicate device.

The guidance leaves unanswered what steps companies should take if they have a low risk device accessory that does not meet the “new” definition. Comments may be submitted regarding this draft guidance through April 20, 2015. 

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Final Guidance)
On February 9, 2015, FDA issued a final guidance on medical device data systems (“MDDS”), medical image storage devices, and medical image communications devices, reaffirming its intention not to enforce regulatory compliance against devices meeting these regulatory definitions. Under 21 CFR 880.6310, an MDDS is a device “intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data.” MDDS does not include devices that (i) are intended to be used in connection with active patient monitoring; [7] (ii) modify the medical device data; or (iii) control the functions or parameters of any connected medical device.

The final guidance confirmed FDA’s intent to exercise enforcement discretion to not enforce compliance with the FDCA’s statutory and regulatory requirements for devices that meet the definition of an MDDS (21 CFR 880.6310), a medical image storage device (21 CFR 892.2010), or a medical image communications device (21 CFR 892.2020). In other words, according to FDA’s final guidance, these devices are not required to register, list, or comply with quality systems regulations or medical device reporting or recall requirements. This is consistent with FDA’s draft MDDS guidance, which was issued on June 20, 2014. While the regulations have not been rescinded and guidance documents do not have the force of law, the guidance document reflects FDA’s current thinking on the matter.

Mobile Medical Applications (Final Guidance)
On February 9, 2015, FDA issued a final guidance regarding mobile medical applications (“mobile apps”). This guidance supersedes the final mobile medical applications guidance previously issued on September 25, 2013. The guidance was updated to be consistent with and reflect the MDDS final guidance issued on the same day. For instance, FDA adds mobile apps that meet the definition of MDDS as an example of a mobile app for which FDA intends to exercise enforcement discretion. Beyond issuing the final guidance document, FDA will continue to update its website with illustrative examples of mobile apps that it does not consider to be medical devices, mobile apps for which it intends to exercise enforcement discretion, and mobile apps that remain the focus of its regulatory oversight. [8]

Conclusion
Collectively, these four guidances reflect FDA’s intent to implement a more closely calibrated risk-based approach to general wellness products, device accessories, medical device data systems, and related medical image storage and communication devices. While clearly welcomed news, we strongly encourage companies to review these guidances closely to understand their scope and limitations.

Notes:
[1] Draft Guidance: General Wellness: Policy for Low Risk Devices (FDA Jan. 2015), available here.

[2] Draft Guidance: Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (FDA Jan. 2015), available here.

[3] Final Guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (FDA Feb. 2015), available here.

[4] Final Guidance: Mobile Medical Applications (FDA Feb. 2015), available here.

[5] Medical Device Accessories Draft Guidance at 4.

[6] Id.

[7] As FDA explained in the preamble to the MDDS regulation, “active” represents “any device that is intended to be relied upon in deciding to take immediate clinical action.”

[8] FDA Mobile Medical Applications, available here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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