Is My Product A Medical Device

Summary

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

00:00

😀 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。

05:04

🔍 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。

10:07

📚 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。

15:08

🤔 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。

20:10

👶 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。

Keywords

💡医療機器

「医療機器」とは、疾病の診断や治療など、医療目的で使用される機器や装置のことを指します。ビデオの主題は、製品が医療機器に該当するかどうかを判断する方法です。例えば、ビデオではタンクデプレッサーや人工心臓など、単純なものから複雑なものまでがある医療機器の多様性について説明しています。

💡FDA

「FDA」はアメリカ合衆国食品医薬品局の略称で、食品や医薬品、医療機器などの安全と効果を監視する政府機関です。ビデオでは、FDAが医療機器をどのように定義し、規制しているかが説明されています。

💡製品の定義

ビデオでは、製品が医療機器に該当するかどうかを判断する際に、その「製品の定義」が重要であると強調されています。製品の意図された使用目的や機能、主張することが明確であることが、医療機器の定義に合致するかどうかを判断する鍵となります。

💡510(k)

「510(k)」とは、医療機器の市場投入前にFDAによる承認を得るプロセスを指します。ビデオでは、510(k)リクエストを通じて、製品が既存の医療機器にどのように比較されるかが議論されています。

💡IVD（体外診断）

「IVD」とは、人体から採取されたサンプルを用いて行われる疾患や状態の検出を行う体外診断テストのことを指します。ビデオでは、IVDが医療機器としてFDAによって規制される理由が説明されています。

💡放射線発出製品

「放射線発出製品」とは、操作中に電子回路を含むだけでなく、電子放射線を放出する製品のことです。ビデオでは、特定の医療アプリケーションを持つ放射線発出製品が医療機器の定義に該当する場合があることが触れられています。

💡モバイルアプリ

ビデオでは、「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可能性があることが説明されています。FDAは、患者にリスクをもたらす可能性のあるモバイル医療アプリケーションに焦点を当てています。

💡Software as a Medical Device (SaMD)

「SaMD」とは、医療目的で使用され、それ自体が医療機器であるソフトウェアを指します。ビデオでは、SaMDがどのように医療機器の定義に適合し、独自の規制の対象になるかが議論されています。

💡一般健康製品

「一般健康製品」とは、健康状態を維持するための低リスクの製品のことであり、FDAによって医療機器として積極的に規制されることがない場合があります。ビデオでは、一般健康製品が医療機器の定義から外れることができる条件が説明されています。

💡組み合わせ製品

「組み合わせ製品」とは、医薬品、医療機器、または生物製品を組み合わせた治療的および診断的な製品のことです。ビデオでは、組み合わせ製品がどのようにFDAによって定義され、その主要な作用メカニズムに基づいてどのセンターが主要な法的責任を持つかが説明されています。

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.