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# Guidance Needed for Drug/Tech Combos: Coalition
- URL: https://www.fdaweb.com/guidance-needed-for-drug-tech-combos-coalition/
- Published: 2016-09-07T12:00:00.000Z
- Updated: 2026-09-14T21:30:06.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5136720

The Clinical Decision Support Coalition is asking FDA for guidance that answers specified questions arising out of three case studies developed by the coalition on issues around a risk-based and clearly defined regulatory system for clinical decision support software that appropriately balances the need for regulatory oversight with the need for innovation and access to new technology. The coalition says its members are a diverse group of stakeholders including software providers, IT infrastructure manufacturers, healthcare providers, medical device and pharmaceutical manufacturers, trade groups, and members of the clinical community.

In an 8/16 citizen [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2497-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com), the coalition says that all over the world, “researchers in universities, drug companies, technology companies, and provider systems are exploring the combination of digital health technologies with pharmaceuticals to achieve not just greater adherence, but better care.”

Factors that the group says are driving the combination of pharmaceuticals and digital health products include: 

- advancements in wearable sensor technology that allow sensing and electronically sharing a huge array of body signals of relevance to treating patients;
- evolution of the Healthcare Internet of Things, allowing for the stitching together of many different electronic constituent parts to allow for a more unified assessment of patient status and monitoring;
- advancements in medicine that allow an understanding of disease progression; and
- advancements in pharmaceutical care that provide a better understanding of how disease progression can be studied and used to more effectively choose the timing and selection of pharmaceutical ingredients.

“All of these advancements, taken together, mean that a new model is emerging for treating disease that considers treatment strategies based on systems made up of many components, not just pills in isolation,” the petition says.

Following discussion of the coalition’s case studies on adherence enhancing digital health products, disease management digital health products, and clinical guideline interpretation products, the petition asserts that FDA guidance does not provide a clear pathway for digital health products used with pharmaceuticals.

“FDA’s current guidance does not provide answers to basic questions about digital health products used with pharmaceuticals, including under what circumstances the software and the wearables might constitute medical devices, and under what circumstances, if they are medical devices, the marketing of the products might trigger combination product status,” it says. "Relying on basic principles from the existing statutes and regulations does allow developers to piece together answers for simple scenarios. For more complex areas, however, FDA has offered no guidance. The importance of guidance cannot be understated in terms of its impact on innovative and product development in this area. The existing uncertainty results in viable, technically sound and potentially clinically valuable projects languishing or being abandoned because the businesses considering them cannot estimate the development costs or timeline without a clear sense of the regulatory pathway.”

The coalition rejects the notion that case-by-case discussion with FDA can solve the problem. It points out that there are many avenues to get information from FDA and that it is unlikely that many people at the agency would be willing to give an off-the-cuff answer to the kind of complex questions being raised. “More fundamentally,” the group says, “this is not a fair system. It replaces the rule of law with the rule of people. If everything is up to the agency in its discretion, there is very little practical oversight of the agency. When the agency commits a view like the classification of a new technology to writing, stakeholders throughout government, patients, providers, and industry all have a chance to express their viewpoints. Relegating these decisions to informal conversations means that sort of public oversight is lost. In the same vein, such a system can be unfair. It does not assure that different companies asking comparable questions are receiving harmonized answers.”

The petition also says that the current formal mechanisms for feedback also are inadequate. It says the processes take too much time when companies are trying to develop innovative software products. And the processes are fairly rigid in that the facts “need to be nicely packaged at the outset, and the narrow and specific answer the company obtains from the agency responds only to a narrow set of facts.

The coalition acknowledges that “creating guidance in this space is a difficult task for FDA. For starters, it is hard to anticipate which direction the technology will go within the general area of software used in tandem with pharmaceutical products…. Guidance that FDA issues could have unintended consequences if it is applied to scenarios that FDA has not previously thought about, because they did not exist…. Moreover, to put it simply, this is hard stuff. If it was not difficult, and if it did not require judgment, industry would be able to figure out the rules based simply on the statutes and regulations. But alas, there are many different issues raised by these scenarios.”

The solution proposed in the petition is for the agency to develop a “new, additional approach to guidance beyond the traditional lengthy and comprehensive guidance document that covers an entire field or regulatory topic.” It suggests that FDA begin to develop guidance, using the good guidance practices, on very narrow specific questions based on a specific set of facts, which the group is calling a “case study guidance.” It says that such a document would have the basic characteristics of an advisory opinion in the sense that it is responsive to an industry-raised topic of general concern, based on a specific set of facts, but it is developed through the guidance development process.

The advantage of a case study guidance to FDA, the petition says, is that it avoids committing broad answers for an entire technological field. “While the agency will certainly need to be mindful of the precedent it sets,” the petition says, “it avoids the risk of crafting general language that is then interpreted by industry as applying to a broad field. This is particularly useful when, as here, the technology field is rapidly evolving.” The approach also saves FDA financial resources, according to the coalition, because it will not have to answer the same questions over and over again.

The document also lists advantages of the approach to industry and to patients.