Is My Product A Medical Device
Summary
TLDRこのビデオスクリプトは、FDAが医療機器をどのように定義し、製品が医療機器に該当するかどうかを判断するためのツールやリソースを紹介しています。医療機器の定義、製品の意図された使用目的、機能、主張を明確にすることが重要であること、さらには、既存の医療機器製品分類を検索し、製品が医療機器として規制されるかどうかを判断する方法について解説しています。また、IVDやモバイルアプリ、ソフトウェアなど、特別な考慮事項も触れ、一般的な健康状態を管理する製品や組み合わせ製品の扱いについても説明されています。
Takeaways
- 📚 FDAは医療機器の定義を示しており、医療機器は単純なものから複雑なものまで多様である。
- 🔍 「私の製品は医療機器ですか?」という質問に答えることは難しい場合があり、FDAの定義を理解することが重要。
- 📝 医療機器の定義には、疾病の診断、治療、緩和、予防、または身体構造や機能への影響を意図することが含まれる。
- 🛠️ 医療機器の定義に含まれないソフトウェア機能についての2016年の変更がある。特定のソフトウェア機能はデバイスから除外される。
- 🤔 製品が医療機器に該当するかどうかを判断する際には、意図された使用目的、機能、主張を明確にすることが必要です。
- 🔗 FDAの公的な製品分類データベースを検索して、既存の医療機器製品分類が存在するかどうかを確認できる。
- 🧪 インビットロ・ダイアグノスティクス(IVD)は医療機器として規制され、血液や組織などの人体から採取されたサンプルに基づくテストである。
- ⚡ 放射線を放出する製品の中には、医療アプリケーションと主張があるものも医療機器に該当する可能性がある。
- 📲 モバイルアプリが医療機器機能を果たす場合、それがプラットフォームにかかわらず医療機器として考慮される。
- 💻 Software as a Medical Device (SaMD) は、独自の医療デバイスとして使用され、医療目的を果たすソフトウェアを指す。
- 🌿 一般の健康状態を維持するための製品で、リスクが低い場合は、FDAによって医療機器として積極的に規制されないことがある。
- 🔄 組み合わせ製品は、薬品、デバイス、または生物学製品を組み合わせた製品であり、その主要な作用メカニズムに基づいてFDAのセンターに割り当てられる。
- 🚫 製品が医療機器の定義に合致しない場合でも、他のFDAセンターによって規制される可能性がある。
Q & A
FDAはどのような製品を医療機器として規制していますか?
-FDAは多様な製品を医療機器として規制しており、単純な舌圧板から人工心臓までがあります。
医療機器の定義を理解するために重要なポイントは何ですか?
-医療機器の定義を理解するために重要なのは、FDAの医療機器の定義を理解することと、製品が医療機器であるかどうかを判断するための異なるアプローチを理解することです。
医療機器の定義に含まれる製品の例として何が挙げられますか?
-医療機器の定義に含まれる製品の例として、診療のための機器、装置、実験室での使用のほか、家庭で使用されるIVD(体外診断)などが挙げられます。
医療機器の定義から除外されるソフトウェア機能には何がありますか?
-医療機器の定義から除外されるソフトウェア機能には、医療施設の行政管理をサポートするソフトウェア、健康な生活を維持・促進するためのソフトウェア、電子患者記録、臨床検査データの転送・保存・フォーマット変換・表示のソフトウェアがあります。
製品が医療機器に該当するかどうかを判断する際に尋ねるべき質問は何ですか?
-製品が医療機器に該当するかどうかを判断する際には、製品の意図された使用目的、製品の機能、そして意図する主張が何であるかを尋ねるべきです。
FDAの公的な製品分類データベースで検索する方法には何がありますか?
-FDAの公的な製品分類データベースで検索する方法には、高度な検索やキーワードを使用したクイック検索があります。
IVD(体外診断)が医療機器として規制される理由は何ですか?
-IVDは人間の血液や組織などのサンプルに基づいて行われるテストであり、疾病や他の条件を検出し、人間の健康状態を監視するために使用されるため、医療機器として規制されます。
モバイルアプリが医療機器に該当する条件は何ですか?
-モバイルアプリが医療機器に該当する条件は、アプリが医療機器の機能を果たすことを意図している場合に該当します。
一般的な健康状態を測定する製品はどのようにしてFDAによって扱われますか?
-一般的な健康状態を測定する製品は、低リスクであり一般的な健康状態を使用目的とする場合、FDAによって積極的に医療機器として規制されることはありません。
組み合わせ製品とは何であり、どのようにFDAによって扱われますか?
-組み合わせ製品とは、薬品、医療機器、または生物学製品を組み合わせた療法や診断製品であり、FDAの異なるセンターによって事前市場レビューと規制を受けます。
製品が医療機器でない場合でもFDAによって規制される可能性がある理由は何ですか?
-製品が医療機器でない場合でも、化学的な作用や体内での代謝によって主な目的を達成する場合は、医薬品としてFDAによって規制される可能性があります。
製品が医療機器であるかどうかを判断する際に、どのような支援をFDAが提供していますか?
-製品が医療機器であるかどうかを判断する際に、FDAは非公式の支援や正式なデバイス決定要求(513(g)リクエスト)を通じて支援を提供しています。
Outlines
😀 FDAの医療機器定義と教育
コマンダーキムベリーはアメリカ公衆衛生サービスの消費者安全官であり、FDAのデバイスと放射線健康センターの産業と消費者教育部門に所属しています。このビデオでは、医療機器の定義を理解するためのツールとリソースを提供し、医療機器の多様性に応じた製品の定義を明確にします。
🔍 医療機器の定義とその特定
医療機器は、単純な舌圧板から人工心臓まで多様です。FDAは医療機器の定義を厳密に守り、製品が疾病の診断、治療、予防に使用されるかどうかを基準に定義します。このセクションでは、医療機器の定義を理解するための4つの学習目標を紹介し、製品が医療機器に該当するかどうかを判断するためのアプローチを説明します。
📚 医療機器の定義と除外されるソフトウェア機能
医療機器の定義は、FD&Cアクトのセクション201(h)に基づいており、その定義は2016年の21世紀キュア法案によって変更されました。この変更では、特定のソフトウェア機能が医療機器の定義から除外されました。除外された機能の例として、医療施設の行政管理、健康維持、電子患者記録、臨床検査データの転送・保存などが挙げられます。
🤔 製品の医療機器適合性の検討
製品が医療機器に該当するかどうかを判断する際には、その意図された使用目的、機能、主張を明確にすることが重要です。IVD、放射線放出製品、モバイルアプリ、Software as a Medical Device (SaMD)、一般健康製品、組み合わせ製品などの特別な考慮事項も触れられています。
👶 大人用と赤ちゃん用のおむつかぶりの医療機器適合性の比較
このセクションでは、大人用おむつかぶりと赤ちゃん用おむつかぶりの医療機器適合性を比較する例を通じて、製品の意図された使用目的を定義し、それが疾病や条件の診断、治療、予防に関連するかどうかを判断します。大人用おむつかぶりは、成人の失禁を治療することを意図しており、医療機器に該当すると判断されます。一方、赤ちゃん用おむつかぶりは、通常の発達過程であり、医療機器には該当しないと判断されます。
📝 医療機器の定義と製品分類の確認
医療機器の定義を確認し、FDAの公的な製品分類データベースを検索して、製品が医療機器として規制されるかどうかを判断します。大人用おむつかぶりについては、既存の製品分類があり、医療機器として規制されることが確認できます。一方、赤ちゃん用おむつかぶりについては、既存の分類に該当しないため、医療機器とはみなされません。
📞 医療機器の判断に関する追加支援
製品が医療機器として規制されるかどうかを判断できない場合、FDAの産業と消費者教育部門やデバイス決定専門家に非公式な支援を求めることができます。正式なデバイス決定が必要な場合は、513(g)リクエストを提出することができます。
Mindmap
Keywords
💡医療機器
💡FDA
💡製品の定義
💡510(k)
💡IVD(体外診断)
💡放射線発出製品
💡モバイルアプリ
💡Software as a Medical Device (SaMD)
💡一般健康製品
💡組み合わせ製品
Highlights
由美国公共卫生服务的指挥官金伯利·皮尔马特奥介绍,她是FDA设备和放射卫生中心的消费者安全官员。
CDRH Learn模块提供了多种工具和资源,帮助确定产品是否为医疗设备。
FDA监管从简单的舌压板到复杂的人工心脏等广泛的医疗设备。
根据FD&C法案第201(h)节,医疗设备被定义为用于诊断、治疗、预防疾病或影响身体结构或功能的仪器。
2016年21世纪治愈法案修订了FD&C法案第520(o)节,排除了某些软件功能作为医疗设备的定义。
确定产品是否符合医疗设备定义时,需考虑其预期用途、功能和声明。
明确产品的预期用途是关键,需识别其诊断、治疗、预防的疾病或条件。
通过检查FDA的公共产品分类数据库,可以帮助确定产品是否符合医疗设备的定义。
体外诊断(IVD)作为医疗设备受到FDA的监管。
某些辐射发射产品,如诊断超声波、X射线机和医疗激光,符合医疗设备的定义。
移动应用程序如果用于执行医疗设备功能,则被视为医疗设备。
软件作为医疗设备(SaMD)是指用于一个或多个医疗目的的软件,且不依赖硬件医疗设备。
一般健康产品如果仅用于一般健康用途且风险低,则可能不受FDA作为医疗设备的积极监管。
组合产品是结合药物、设备和/或生物制品的治疗和诊断产品。
如果产品不满足医疗设备的定义,可能仍受FDA内其他中心的监管。
通过实例演示了如何确定成人尿布和婴儿尿布是否符合医疗设备的定义。
如果无法确定产品是否受FDA作为医疗设备监管,可以请求非正式或正式的设备确定帮助。
CDRH提供了多种行业教育资源,包括CDRH Learn和Device Advice。
熟悉医疗设备的定义和如何搜索FDA公共产品分类数据库,有助于确定产品是否为医疗设备。
Transcripts
Hello, my name is Commander Kimberly
Piermatteo of the United States Public Health
Service and I am a Consumer Safety Officer
within the Division of Industry and Consumer
Education at FDA's Center for Devices and
Radiological Health.
Welcome to CDRH Learn, CDRH's resource for
multimedia industry education.
Answering the question “is my product a medical
device?”
can often be challenging.
During this CDRH Learn module I will provide you
with various tools and resources to better equip
and prepare you to answer this question.
FDA regulates a wide range of diverse products as
medical devices.
Medical devices may be as simple as a tongue
depressor and as complex as an artificial heart.
Because of the wide range of medical devices, it is
important to gain a better understanding of how FDA
defines medical devices, as well as to understand
different approaches to determine if your product
is a medical device or not.
To help you gain a better understanding, I will be
covering the following four learning objectives
in this module.
The first learning objective is to define
what the FDA considers to be a medical device.
Next, I will discuss various topics to consider
when determining if your product meets the
definition of a medical device.
Thirdly, I will walk through a device
determination example.
And lastly, I will identify informal and
formal ways for you to request further
assistance, if you need.
To begin, let's first review the FDA's
definition of a medical device.
Slide 5 According to Section 201(h) of the
Federal Food, Drug & Cosmetic Act or what is
also referred to as the FD&C Act, a medical 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:
recognized in the official National Formulary, or the
United States Pharmacopoeia, or any
supplement to them, OR is 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 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 is not
dependent upon being metabolized for the
achievement of its primary intended purposes.
The term "device" also does not include software
functions excluded pursuant to section
520(o).” The first dash on this slide distinguishes a
medical device from a drug.
The second dash covers an amendment to section
520(o) of the FD&C Act, which I will discuss
further on the next slide.
The amendment to section 520(o) of the FD&C Act was
made in December of 2016 as part of the 21st
Century Cures Act.
This amendment removed certain software functions
from the definition of a device.
On this slide I have provided some examples of
excluded software functions such as those
software functions intended...For the
administrative support of a health care facility;
Software functions for maintaining or encouraging
a healthy lifestyle and is unrelated to the
diagnosis, cure, mitigation, prevention, or
treatment of a disease or condition; Software
functions which serve as electronic patient
records; and lastly, software functions for
transferring, storing, converting formats, or
displaying clinical laboratory test or other
device data, results or findings but which are not
intended to interpret or analyze them.
I encourage you to thoroughly review section
520(o) of the FD&C Act if you believe you may have a
software function that might be excluded from the
definition of a medical device based on this
amendment.
When determining if your product meets the
definition of a medical device you should ask
yourself the following questions: What is the
intended use of your product?
How does your product function?
And what claims do you intend to make?
By clearly addressing these questions, you will
be better able to determine if your product
meets the definition of a medical device.
I'd like to emphasize that defining your intended use
is key.
You should clearly state and understand the general
purpose or function of your device, as well as
identify the disease or condition it is intended
to diagnose, cure, mitigate, treat or
prevent.
You should also be able to identify the intended
patient population, such as if the device is
intended for use on adult and/or pediatric patients.
All of these characteristics which make
up the intended use of your device are important
because if a product is labeled, promoted or used
in a manner that meets the definition in section
201(h) of the FD&C Act, the product will be
regulated by the FDA as a medical device and will be
subject to premarket and postmarket regulatory
controls.
One approach to help you determine if a product
meets the definition of a medical device is to check
and see if there is an existing FDA medical
device product classification.
If you are able to identify an applicable
product classification which appropriately
describes your product's intended use or design,
this would be a good indication that your
product would be regulated as a medical device.
To determine if an existing medical device
product classification exists, you may search the
FDA's public Product Classification database.
On this slide I have provided you a screen shot
of what this database looks like and a hyperlink
to this database.
The default search is the advanced search from which
you can search various fields, such as by
searching for the FDA product code, regulation
number, or device class.
I always recommend stakeholders search by key
word using the quick search.
The quick search allows you to capture a wider
range of potential product classifications and then
you can narrow them down to identify the most
appropriate one for your proposed device.
Later in this module, I will walk you through a
search of the FDA's public Product Classification
database as part of the device determination
example.
Over the next several slides, I will be
discussing a few special considerations for you.
These topics should be considered when
determining if your product meets the
definition of a medical device or not.
The first special consideration is regarding
In Vitro Diagnostics or IVDs.
The FDA regulates IVDs as medical devices.
IVDs are tests done on samples such as blood or
tissue that have been taken from the human body.
These tests can detect diseases or other
conditions and can be used to monitor a person's
overall health to help cure, treat, or prevent
diseases.
Some tests are used in laboratory or other health
professional settings and other tests may be used at
home by consumers.
Examples of a few common IVDs include a home
pregnancy test and a blood glucose test strip.
If you intend to market an IVD it may meet the
definition of a medical device and therefore would
be regulated by the FDA.
At the end of this module, on the resources slides, I
have provided links where you can access additional
information related to IVDs.
Another consideration is regarding radiation
emitting products.
Section 531 of the FD&C Act defines an electronic
product as a product which, when in operation,
one, contains or acts as part of an electronic
circuit and, two, emits electronic product
radiation.
Most radiation emitting products are not
considered to be medical devices.
However, certain radiation emitting products with
medical applications and claims meet the definition
of a medical device and therefore must comply with
both the medical device regulations as well as the
electronic product regulations.
Examples of radiation emitting products which
also meet the definition of a medical device are
diagnostic ultrasounds, x-ray machines and medical
lasers.
Links to where you can find more information on
radiation emitting products and the
electronic product regulations are found on
the resources slides at the end of this module.
Next, if you have a mobile application or mobile app
it may be considered a medical device.
If a mobile app is intended for use in
performing a medical device function, it would
be considered a medical device, regardless of the
platform on which it is run.
The FDA intends to focus its regulatory oversight
on a subset of mobile apps that present a greater
risk to patients if they do not work as intended.
This subset is represented by the small red circle on
the image on this slide which I have drawn
attention to using the yellow arrow.
The FDA refers to this small subset of mobile
apps as mobile medical applications or MMAs.
MMAs are software programs that run on mobile
platforms and perform the same functions as
traditional medical devices.
The FDA's guidance document on Mobile Medical
Applications outlines the FDA's tailored approach to
mobile apps in more detail.
You may access this guidance via the link
provided at the bottom of this slide.
Another special consideration is that
software, which on its own is a medical device, is
referred to as Software as a Medical Device or SaMD.
The FDA considers software intended to be used for
one or more medical purposes that perform
these purposes without being part of a hardware
medical device to be SaMD.
An example of a SaMD is, software that allows a
smartphone to view images obtained from a magnetic
resonance imaging or MRI for diagnostic purposes.
More information is available on the Software
as a Medical Device webpage and a link to this
webpage is provided at the end of this module on the
Resources slides.
The next special consideration I would like
to discuss is about general wellness products.
If your product is intended for general
wellness use only, and is low risk, it may not be
actively regulated by the FDA as a medical device.
According to the FDA guidance document titled,
General Wellness: Policy for Low Risk Devices,
which can be accessed via the link provided at the
bottom of this slide, CDRH defines general wellness
products as products that meet the following two
factors, those that are intended for only general
wellness use, as defined in the guidance, and those
which present a very low risk to users' safety.
The guidance document also states CDRH does not
intend to examine low risk general wellness products
to determine whether they are devices within the
meaning of the FD&C Act or, if they are devices,
whether they comply with the premarket and post
market regulatory requirements for devices
under the FD&C Act.
You should review the General Wellness guidance
document thoroughly if you believe your product may
meet these factors and therefore would not be
actively regulated by the FDA as a medical device.
Another consideration is combination products.
Combination products are defined in the code of
federal regulations or CFR, under 21 CFR 3.2(e),
as therapeutic and diagnostic products that
combine drugs, devices, and/or biological
products.
A combination product is assigned to an FDA Center
or alternative organizational component
that will have primary jurisdiction for that
product's premarket review and regulation.
Under section 503(g)(1) of the FD&C Act, assignment
to the center with primary jurisdiction, or what is
also referred to as the lead center, is based on a
determination of the “primary mode of action”
of the combination product.
A few examples of different types of
combination products include a drug eluting
stent, a heparin coated dialysis catheter, and a
first-aid kit with a drug.
A link to the FDA's combination products
homepage is provided on the resources slides at
the end of this module.
The last special consideration I would like
to mention is if you determine your product
does not meet the definition of a medical
device, it may still be regulated by another
Center within the FDA.
If the primary intended use of the product is
achieved through chemical action or by being
metabolized by the body, the product is usually a
drug.
Human drugs are regulated by the FDA's Center for
Drug Evaluation and Research.
Biological products which include blood and blood
products, as well as blood banking equipment are
regulated by the FDA's Center for Biologics
Evaluation and Research.
The FDA's Center for Veterinary Medicine
regulates products used with animals.
And the FDA's Center for Tobacco Products regulates
tobacco products including vaporizers and electronic
cigarettes.
If you believe your product is regulated by
another FDA Center, you may contact that Center to
discuss potential regulatory requirements.
I have provided links to the other Centers on this
slide and from those webpages, you will be able
to find their respective contact information.
Next, I will walk through an example of how to
determine if a product meets the definition of a
medical device.
For this device determination example, the
two products I'm going to assess and determine if
they meet the definition of a medical device are an
adult diaper and an infant diaper.
Defining the intended use of your product is key.
In this example, the broad intended use for both
diapers is to protect garments from urine or
stool.
This broad use doesn't exactly tell me if one or
the other is intended to treat a medical condition.
Therefore, I will expand upon and describe the
disease or condition each diaper is intended to
treat.
The inability to control leaking urine or stool is
often referred to as incontinence.
For an adult, incontinence is considered to be a
medical condition.
For an infant, incontinence is not
considered a medical condition since it is
normal for an infant to not be able to control
their elimination until they are of an appropriate
age.
Therefore, I can further define each product's
intended use with the adult diaper being
intended to treat incontinence and the
infant diaper is not.
To help me evaluate whether these products
meet the definition of a medical device, I'm going
to break down the medical device definition into
three questions.
These questions are outlined on the table
provided on this slide.
By answering these three questions, I will be able
to determine whether the adult diaper, the infant
diaper, or both meet the definition of a medical
device.
The first question I going to ask myself is whether
the product is intended to diagnose, cure, mitigate,
treat, or prevent disease in a human?
My answer for the adult diaper is yes, it is
intended to treat incontinence in adult
patients.
As for the infant diaper, the answer to this
question is no, it is not intended to treat a
medical condition in babies or infants.
The second question I'm going to ask is whether
the product is intended to affect the structure or
any function of the body.
For both, I can answer no, because neither product
physically impacts the structure or function of
the body.
The third question I'd ask is whether the product
achieves its primary intended purpose by
chemical action or by being metabolized.
Again, for both, I can answer no.
Therefore, based on addressing these three
questions which break down the medical device
definition, I can now answer the question
whether the product meets the definition of a
medical device.
The adult diaper does meet the definition of a
medical device, but the infant diaper does not.
Let's say I'm not sure if either diaper would be
considered a medical device after reviewing the
medical device definition.
I can search the FDA's public Product
Classification database to determine if there is an
existing product classification appropriate
for either diaper.
If I'm able to find one, and it appropriately
describes either diaper then yes, I can conclude
that either or both would be regulated as a medical
device.
On this slide, I have again provided a screen
shot and link to the public product
classification database.
To determine if there is an existing product
classification for either diaper, I'm going to
utilize the Quick Search which is circled in red on
this slide.
This slide shows what the Quick Search looks like in
the Product Classification database.
By using the quick search, I can conduct numerous
searches using a variety of related terms including
the term diaper or urine.
However, I often find it more beneficial to search
using a key word which describes the disease or
condition the product is intended to treat.
Thinking back when I further defined the
intended use of both diapers, I determined that
the adult diaper was intended to treat
incontinence, therefore, I am going to search using
incontinence as my key term, which I have circled
in green on this slide.
On this slide, I have provided a screen shot of
my search results when I used the key word
incontinence.
As circled in red on this slide, I was able to
identify 23 potentially related product
classifications.
After reviewing these results, I do see one
device specifically titled garment, protective, for
incontinence.
From the product classification database, I
could select the hyperlink for the product code EYQ
for this device or select the hyperlink for the
device description title.
Either selection will take me to additional
information about this device, which I can then
review and determine if the description
appropriately describes either the adult or infant
diaper.
For this example, I'm going to select the
hyperlink to the device name to further review the
information.
This slide includes a screen shot of the product
classification results for a protective garment for
incontinence.
A lot of regulatory information is provided,
however for this example I'm specifically looking
at whether there is an existing product
classification which appropriately describes my
product.
Therefore, to review a detailed device
description, I can review the regulation
description.
To do this, I'm going to select the hyperlink for
the regulation number 876.5920 which I have
circled in red on this slide.
According to the regulation 21 CFR
876.5920, this type of device is described as...
A protective garment for incontinence that consists
of absorbent padding and a fluid barrier and that is
intended to protect an incontinent patient's
garment from patient's excreta.
This description sounds very much like the adult
diaper in my example.
Even more specifically, this regulation states
that this device type does not include diapers for
infants.
To summarize this device determination example,
after reviewing the regulation description and
comparing it to the intended use of the adult
diaper and the infant diaper, I can now answer
the question “Is there an existing product
classification?”
For an adult diaper the answer is yes, there is an
existing classification; however, for the infant
diaper there is not, so the answer is no.
Tying this back to my original intent for this
example, which was to determine whether either
diaper would be regulated as a medical device, I can
conclude that because there is an existing
classification for the adult diaper, yes, it
would be regulated as a medical device.
And the infant diaper would not be considered a
medical device because the existing classification I
did find, specifically excluded infant diapers.
If after reviewing the definition of a medical
device and searching for an existing product
classification you are unable to determine if
your proposed product would be regulated as a
medical device, you may consider requesting
further assistance.
If you would like informal assistance, you may
contact the Division of Industry and Consumer
Education or the Device Determination experts.
DICE may help you better understand the resources
available to you and assist you in searching
the product classification database to identify
potentially relevant existing product
classifications.
If after you have utilized the resources available to
you, or if you cannot make a determination, you may
contact the Device Determination experts.
Please note, responses to either informal assistance
mentioned on this slide are not classification
decisions and do not constitute FDA clearance
or approval for commercial distribution of your
product.
If you would like a formal device determination from
the FDA, you should consider submitting a
513(g) Request.
For instructions on how to submit a 513(g) Request,
refer to the FDA guidance document titled FDA and
Industry Procedures for Section 513(g) Requests
for Information under the Federal Food, Drug and
Cosmetic Act.
A link to this guidance is provided on this slide.
Lastly, please note, FDA's response to a 513(g)
Request does not constitute FDA clearance
or approval for commercial distribution.
In summary, medical devices are defined under
Section 201(h) of the FD&C Act.
As a reminder, a clearly defined intended use is
key when you are trying to determine if your product
meets this definition.
You may also search for an existing medical device
product classification and if you find an applicable
one, then you can presume that product is likely
regulated as a medical device.
And lastly, further assistance regarding
device determinations, both informal or formal,
is available to you if needed.
Additional resources and links are provided on the
next few slides.
I will not cover them in detail but they are listed
for your reference as needed.
CDRH provides multiple opportunities for industry
education.
On this slide, I have provided you links to CDRH
Learn which consists of numerous learning modules
covering a wide range of medical device topics; as
well as Device Advice, which is a text-based
resource, and lastly, you may contact the Division
of Industry and Consumer Education or DICE by phone
or email with questions.
I leave you with this call to action - familiarize
yourself with the definition of a medical
device as well as how to search the FDA's public
product classification database.
By familiarizing yourself with both of these, I hope
if you are presented with the question, is my
product a medical device in the future, you will
feel more equipped and confident to answer it.
Thank you for watching and I hope you have found this
module helpful.
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