Streamlining the Regulatory Path to Market for Low-Risk Med Devices | Page 2
Determining Whether the Product Is a Device
In Chapter 9, Section 201 of the Federal Drug & Cosmetic (FD&C) Act, a device is defined as an instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, that is—
RECOGNIZED IN THE OFFICIAL NATIONAL FORMULARY, the United States Pharmacopeia,
or any supplement to them
INTENDED FOR USE IN THE DIAGNOSIS of disease or other conditions or in the cure,
INTRODUCTION
Medical devices are life-enhancing and lifesustaining products that encompass a vast spectrum
of products, from bandages to pacemakers. USbased companies dominate the roughly $350 billion
global medical device industry, and, as a result,
America exports more medical devices than it
imports.1 The U.S. Food and Drug Administration
(FDA) is responsible for regulating firms that
design, manufacture, repackage, relabel, or import
medical devices sold in the United States. The FDA
categorizes medical devices into three classes based
on the level of regulatory control needed to provide
reasonable assurance of safety and effectiveness.
Because Class III devices pose a potential for
serious risk to humans, all Class III devices must
be evaluated in clinical trials before receiving
Premarket Approval from the FDA. As with medical
drugs, clinical trials for medical devices take a
lot of time and cost a lot of money. In general,
the clearance process for Class I and II devices
is simpler and commonly does not require novel
clinical trial data. Class I and II devices rely mostly
on safety and performance data in accordance
with quality regulations and consensus standards.
Especially when clinical trials are not required,
developing Class I and II devices is very feasible for
small companies without large capital reserves.
Once a device receives clearance for sale in the
United States, expanding into global markets can
be relatively simple because the FDA is a globally
2
mitigation, treatment, or prevention of disease in man or other animals
INTENDED TO AFFECT THE STRUCTURE or any function of the body of man or other
accepted health authority that has partnerships with
other major markets. Most of the documentation
and testing required for the FDA is accepted in the
European Union, Canada, and some countries in
Latin America as well as the Asia-Pacific region.
Although the process of FDA clearance for Class I
and II medical devices is simpler than for medical
drugs and Class III devices, the various submission
standards are not always obvious or intuitive, and
failure to properly navigate them can lead to wasted
resources at best and federal prosecution at worst.
Following is a breakdown of important steps in
receiving FDA clearance of Class I and II medical
devices and strategies for streamlining the process.
‘‘
US-based companies
dominate the roughly
$350 billion global
medical device industry,
and, as a result, America
exports more medical
devices than it imports.1
animals and does not achieve its primary intended purposes through chemical action within
or on the body of man or other animals and is not dependent upon being metabolized for the
achievement of its primary intended purposes.2
Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not
medical devices. However, the results achieved by medical devices may be assisted by these means.
Per the FD&C Act, companies cannot sell, transport, distribute, or export Class II or III devices without
FDA clearance or approval. In contrast, most Class I devices are exempt from FDA review and can be
commercialized after the manufacturer or distributor registers their establishment with the FDA.3 Failure
to register as a device establishment or to list a medical device with the FDA can result in advisory actions
(warning letters), administrative actions (administrative detention, recalls, and civil penalties), or judicial
actions (seizures, injunctions, and criminal prosecutions).4
Figure 1. Important Steps in
Receiving FDA Clearance and
Strategies for Streamlining
the Process
STEP 3
STEP 2
Confirming the
Classification
Understanding the
Classes and Corresponding
Regulatory Controls
STEP 5
Defining the
Medical Device
STEP 1
Determining Whether
the Product is a Device
ü
STEP 4
Identifying Predicate
Devices Already
Cleared for Sale
STEP 6
Developing
a Regulatory
and Strategic
Pathway