What is a Medical Device according to FD&C Act?

In this article, you will learn what is a Medical Device as per Food, Drug, and Cosmetic Act (FD&C Act).

Introduction: A medical device is a product, such as an instrument, machine, implant,  or in vitro reagent, that is intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.

A medical device as defined in Section 201(h) of the Food, Drug, and Cosmetic Act, 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 a 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).

To establish if a product meets the definition of a medical device, define the intended use and indications for use of the product.

Once is defined the intended use and indications for use of the product, determine if the product meets the definition of a medical device.

How to Determine if Your Product is a Medical Device

Determine your product classification

Search the Product Classification Database

Search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product:

• Use the Quick Search feature to search by keyword(s). Please note, you may need to conduct multiple searches using a variety of keywords that describe your product (for example, search both “stent” and “stents”).
• Use the Advanced Search feature to search by product code, regulation number, or device class.

For further information on how to classify a medical device, please refer to the How to Classify Your Device page.

Need help & support with your medical devices or need templates to create a quality manual and other procedures, visit us,

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT MEDICAL DEVICES PER FOOD, DRUG, AND COSMETIC ACT.

For more details on specific FDA expectations and how to create quality management system documents necessary, follow us.

Three (3) Options to Create Quality Management Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the quality procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on Medical Devices?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Management Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

REFERENCES:

For more information about Medical Devices, refer to:

Mobile Medical Applications

Software as a Medical Device

Digitalhealth@fda.hhs.gov.

• General Wellness: Policy for Low Risk Devices.
• FDA Combination Products
• Center for Biologics Evaluation and Research (CBER) regulates biological products.
• Center for Drug Evaluation and Research (CDER) regulates human drugs.
• Center for Veterinary Medicine (CVM) regulates products intended for animal use.
• Center for Tobacco (CTP) regulates tobacco products.

Further Assistance

Division of Industry and Consumer Education (DICE).

DeviceDetermination@fda.hhs.gov.

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Guidance (2012).