It may seem straightforward to determine if a product is a medical device or not but there is a surprising amount of gray-area in the field. The term “medical device” covers a simple tongue depressor to an implanted pacemaker and everything in between. A simple wooden stick is one product-development decision away from either being a popsicle stick, or a tongue depressor that crosses into a strict world of regulatory requirements...

1. Determining if your Product is a Medical Device
By: Madison Wheeler
It may seem straightforwardto determineifa product is a medical device or not but there is a surprising
amount of gray-area in the field. The term “medical device” covers a simple tongue depressor to an
implanted pacemakerand everything in between. A simple wooden stick is one product-development
decision away from either being a popsiclestick, ora tongue depresso rthat crosses into a strict world of
regulatory requirements.
The first step in determining ifyourproduct is a medical deviceis looking at how the law defines “medical
device”.Section 201(h) ofthe Food, Drug, and Cosmetic act lays out explicitly what is legally considered a
device;put simply, a medical device is any product thatdiagnoses,treats, or prevents a disease/condition
by affecting any structure or function ofthe body without chemical action (meaning it is not a
pharmaceutical drug).1 The first thing any product development team should do is define the intended use
and indications for use ofyourproduct,and then compareit against Section 201(h) ofthe FD&C Act to
determine ifit’s a medical device.
After you havedefined the intended use ofyour product and compared it against the law, the next step
should be determining ifthere is an existing FDA product classification that your product could fit into. If
your product can fit into an already existing classification, it is a good indicator that it is a device. The
FDA has several public and searchabledatabases that can aid in this endeavor, such as the product
classification database, the Establishment Registration and DeviceListing database,and any ofits
marketing authorization databases (such as PMA or De Novo).2 It’s important to remember thateven if
you can’t find a similar classification or device in these databases, it doesn’t necessarily mean your
productisn’t a medical device –it might just be the first of its kind!
As technology advances, the boundaries ofclassical medical devices are stretched further and further.
Mobile medical applications or software as a medical device (SaMD) are emerging trendsthat are new to
the field and thereforemay notbe completely obvious that they fall into the regulatory landscape.
Additionally,combination products areproducts that combinea device and a drug or biologic and can fall
under the device requirements depending on the defined intendeduse. Even ifyour product is not a
device, it may be regulated by anothercenter within the FDA such as the Center for Biologics Evaluation
and Research (CBER).
A seemingly straightforward question like “Is my product a medical device?” can lead many firms down a
confusing path. EMMA International has a team ofregulatory experts thatcan not only help you
determine ifyourproduct is a medical device but also guide you on how to get yourproduct on the market
and ensure its compliance. Give us a call at 248-987-4497 or email info@emmainternational.com to see
how we can help!
1 FDA(September 2017) Classification ofProducts as Drugs and Devices andAdditionalProduct Classification Issueretrievedon 08/30/2020
from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-
product-classification-issues#:~:text=For%20a%20medical%20product%20also,primary%20intended%20purposes%20through%20chemical
2 FDA(December 2019) Howto Determine ifYour Product is a MedicalDevice retrieved on 08/30/2020 from: https://www.fda.gov/medical-
devices/classify-your-medical-device/how-determine-if-your-product-medical-
device#:~:text=If%20you%20identify%20a%20similar,the%20classification%20of%20your%20device.