We Dispel Regulatory Uncertainty

In health care a surprising range of products can be regulated by the FDA; this can be a key source of business uncertainty. Managing uncertainty is necessary for reliable planning and achieving key business milestones such as product development and launch, sales and the generation of revenue and profit.

Phases of a Regulatory Engagement


Regulatory Strategy

Regulatory strategy impacts a product's value proposition, competitive position, the time required for FDA review, and sustaining engineering costs. Whether your product is regulated or not, it is critical to understand what specific claims and labeling can push your product from being regulated or not. Identifying potential product classifications and predicate devices identifies possible regulatory paths and minimizes FDA review time. A good strategy will also seek to minimize sustaining engineering costs that can arise due to the wide use of off-the-shelf IT hardware and software.

Quality System

They say, quality is its own reward. And in fact it is impossible to buy a toilet at Home Depot that is not developed and manufactured following a quality system. Regulated manufacturers must follow the FDA's quality system, which is similar to ISO9001. A review of your current company policies and procedures results in a quality system gap analysis. Next, a plan details the process and time required to implement the quality system. The least disruptive and lowest cost approach is to take 6 months or more to implement your quality system. The implementation plan is executed along a series of milestones including policies, procedures, forms, training and guidance during implementation.


FDA Submissions

Innovative or disruptive products may benefit from prospective guidance from FDA — which they are happy to provide. Such interactions must be managed carefully as FDA "guidance" often becomes mandates for an actual submission. Submissions must be unambiguous and complete, and often FDA responds with questions that must be answered before an FDA clearance or approval is received. The submission process can be especially complex when implementing a quality system at the same time. Often, required artifacts must be completed retroactively when design or testing was done prior to quality system implementation.

Regulatory issues for many companies exist somewhere in the gray zone of regulatory uncertainty. Choices made for the intended use, marketing claims, and product classification — along with certain product features — are all interrelated. Finding the optimal regulatory strategy is an iterative process, weighing trade-offs carefully.

Once your strategy is defined, it is time to execute. Our experience helps assure that your quality system and resulting artifacts will meet FDA scrutiny during an FDA inspection or review of a submission.

If you've never been regulated, its not as bad as you imagine — but it is important to have someone who can show you the way.

Take your next step to defining your regulatory strategy.

Schedule a free 30 minute consultation to discuss your situation and next steps.
We will review your current situation, short and mid term objectives, and discuss next steps for moving you towards your goal.

Is My Product Really a Medical Device?

For many, it is not clear whether their product is a regulated medical device. What follows is the legal definition of a medical device.

If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it may be regulated by the FDA as a medical device and subject to premarketing and postmarketing regulatory controls.

A device is:  "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

      1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
      2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
      3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o)."

Under sections 520(o)(1)(A)-(D) of the FD&C Act (21 U.S.C. 360j(o)(1)(A)-(D)), as added by the 21st Century Cures Act, certain medical software functions are not medical devices, including software functions that are intended (1) for administrative support of a health care facility, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, or (4) for transferring, storing, converting formats, or displaying data.

Besides conventional medical devices, a regulated device can include application software and even services.

Regulatory Uncertainty

The definition of a medical device is very inclusive. This broad definition is balanced against the FDA's limited resources which cannot possibly regulate every product that meets the legal definition. A key factor, among several that the FDA uses to best focus their resources is patient safety. Other examples of enforcement discretion are described below.

Products sold into health care can be divided into three areas: those that are clearly regulated, a large gray area where there is some ambiguity whether a product is regulated or not, and those products that are clearly not regulated.

Clearly Regulated

Hardware and software products clearly meeting the legal definition of a medical device are regulated. The is an extensive body of regulated hardware from pacemakers to patient monitors to patient beds to tongue depressors. FDA has regulated application software for many years. Examples include software for calculating insulin doses for tight glycemic control, software that detects diagnostic abnormalities in x-rays or MRI scans, and certain clinical decision support software. Medical device systems, such as smart pumps, made up of medical devices, server software and client applications are all regulated as a single medical device system.

Adding connectivity to embedded system medical devices introduces a new kind of technology — network enablement, application software and off-the-shelf computer equipment — that often requires a regulatory strategy different from the embedded system device itself.

Gray Areas

There are many levers available to manufacturers and the FDA to determine whether a product is regulated or not. The following are just four examples of scenarios where the regulatory question could be answered either way.

Some products can be regulated or not depending on how they are labeled, promoted or used. A wireless home weight scale and associated smartphone app intended for weight loss by those seeking health improvement are not regulated. The same wireless weight scale and smartphone app intended to monitor weight changes for congestive heart failure patients is a regulated medical device. It is up to the manufacturer to determine which marketing claims and intended use will generate the most sales and profit for their product — in this case, a general health and wellness claim or a chronic disease management claim.

In a related example, sometimes new products developed by regulated medical device manufacturers for use with their regulated products are not regulated. Despite FDA's final guidance on accessories, some manufacturer's HL7 integration engines intended to transfer medical device data into the patient's EMR record are not regulated devices. While such a product clearly meets the definition for a medical device accessory (and consequently would be regulated to the same extent as the medical device to which it is an accessory) some of these products are not regulated while some are.

Some product categories have competitors who are regulated and some who are not. Nurse call systems and hospital supply chain dispensing cabinets are two examples. In both of these markets, some manufacturers have their products regulated by the FDA and some do not. Some may chose to be regulated when they don't really have to for convenience, as a way to to create a competitive barrier to entry, to meet a buyer preference for a regulated product or to be able to make certain marketing claims that push the product into regulated territory.

Emerging technologies and related markets often start out as regulatory gray areas. Examples of current gray areas for emerging technology and markets include some digital health applications, clinical decision support systems and artificial intelligence solutions. When innovative new solutions come to market for which there are no pre existing established products, the FDA will typically exercise enforcement discretion (choose not to enforce the regulations) and observe the market develop (with particular focus on patient safety). As the market matures and adoption increases the FDA will eventually step in, announce they are planning to regulate and how, and provide the market with dates vendors need to meet to come into compliance. In these cases, companies can start without the full regulatory burden while they (and the market) get established. But eventually they will need to make the changes required to become regulated — when and how they make that transition are important considerations. Typically FDA does not explicitly state that they are pursuing enforcement discretion in a particular emerging market, but they have made public statements with regards to digital health.

Clearly Not Regulated
The FDA has long noted that "automated record keeping" software is not regulated. With the 21st Century Cures Act, the four categories of software listed under section 502 (o) mentioned above are also explicitly not regulated.  Products that do not have health care specific marketing claims or intended uses are clearly not regulated. Examples of this include general purpose IT and telephony hardware and software, many fixtures and furnishings and similar products. As noted above, a smart pump system may be regulated but the off-the-shelf IT components (e.g., smartphones, tablets, network switches, software libraries) are not regulated in and of themselves.
Tim Gee

Tim Gee


When I started in health care in the 1980s, I worked for a startup in an emerging market automating cath lab study data analysis and reporting — we and a few competitors were not regulated. The FDA was watching; one day an FDA inspector made an unannounced visit, spending several hours asking questions and inspecting documents. The FDA regulated this market a few years later.

Since then, regulatory issues have been a key part of my focus in product life cycle management. I have made it my business to cultivate a deep understanding of regulatory affairs and how regulatory strategy impacts product success. I've been consulting and writing about regulatory issues for for more than 10 years and the blog posts listed below provide examples of some of my knowledge and understanding of regulatory issues.

Patricia Landers Gee

Patricia Landers Gee


Another health care lifer, Patricia brings over 25 years in medical device product development and marketing. Besides working for companies who ran a tight ship regulatory-wise, she also worked for a manufacturer under an FDA consent decree precluding the manufacturer from shipping product. Here there was a heightened focus on regulatory compliance where she worked on product development, labeling and marketing.

Regulatory issues have been a key part of Patricia's work for the past 25+ years. Quality system artifact creation, the product development process and labeling have been her focus — along with seeking opportunities for continuous improvement from good to great.


What It Means to Be Regulated

The impact when you are regulated by the FDA is real, but may be less than you imagine. Being regulated means you must do these four things:

  1. Register with the FDA as a medical device manufacturer and pay an annual fee
  2. Implement and follow the FDA Quality System (similar to ISO9001)
  3. File the artifacts generated by following the quality system
  4. Depending on your product's classification, you may need to submit certain artifacts to FDA for premarket clearance or approval

Avoid these potential regulatory pitfalls

Unanticipated FDA Enforcement
When the FDA comes knockin' on your door — and eventually they will — you may be the recipient of a form 483, a warning letter, or even an adulterated product seizure. A bit of foresight and upfront work can prepare you avoid enforcement and, if necessary, justify the decisions that define your regulatory posture.
The Need to Rush to Become Compliant
Implementing a quality system, or even creating quality system artifacts from before you had a quality system takes time away from primary job responsibilities, especially product development. A long term regulatory plan allows you to plan for additional regulatory tasks in a way that minimizes disruption and cost.
Delays in Receiving FDA Clearance or Approval for Your Product
Most submissions result in a few questions and requested minor changes to the submission that can delay clearance by a few or several weeks. Major errors in product classification, predicate devices and/or incomplete or confusing portions of a submission can result in substantial unplanned delays in gaining FDA clearance or approval, greatly delaying product launches and revenue.
Larger Than Necessary Sustaining Engineering Costs
Most IoMT and medical device connectivity products include a large portion of off-the-shelf computer hardware and software. The suppliers of these off-the-shelf components can change their products as frequently as every 18 months. Without an optimized regulatory strategy, these changes can mean a substantial amount of engineering and verification and validation testing for each change. With the right regulatory strategy it is possible to minimize these unplanned reactions to supplier product changes.

Increase your Regulatory IQ

The following articles provide some background, analysis and a bit of prognostication on regulatory issues.

Managing Digital Health Regulatory Uncertainty

Uncertainty abounds when managing digital health regulatory uncertainty regarding the FDA and other international regulatory bodies. For this discussion we'll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential...

FDA Busy With Software

Since connectivity runs on software, and some medically related software is a medical device, and medical devices are regulated by the FDA, those involved in connectology must pay at least some attention to what the FDA is saying about the subject of medical software...

FDA Guidance on Software Changes

On October 25, 2017 the FDA released its guidance on "Deciding When to Submit a 510(k) for a Software Change to an Existing Device". A draft of this guidance was released in August 2016 and I commented on that draft here. The scope of what was changed is not easy to...

Sussing Out SaMD — Software as a Medical Device

Software as a Medical Device (SaMD) is terminology under the aegis of a work group of the International Medical Device Regulators Forum (IMDRF) of which the FDA is a member. SaMD is distinct from software in a medical device although "in" these days may have a looser...

Charting Your Regulatory Course

Do you think your product could be a regulated medical device? There are all kinds of regulatory strategies. Any new product development project for a regulated product should have a regulatory strategy that optimizes requirements, specifications, risk and...

Impact of Modifying FDA Regulated Devices

Unfortunately for you, congress did not wish to extend the physician exemption to hospitals.

Facing FDA Regulations for the First Time

What are your risks in being part of a regulated device, and what can you do to make yourself a more attractive supplier?

TAKE YOUR NEXT STEP TO defining Your Regulatory Strategy.

Schedule a free 30 minute consultation to discuss your situation and next steps.
We will review your current situation, short and mid term objectives, and discuss next steps for moving you towards your goal.