Are there special labeling requirements for investigational devices?
Are there special labeling requirements for investigational devices? Yes. Under § 812.5 an investigational device or its immediate package must bear a label with the following information: the statement, “CAUTION Investigational device.
What is required on a medical device label?
There is a very clear requirement that labeling must clearly identify the manufacturer of the device, including their name and place of business. If the device is manufactured for or distributed by another company, this must be shown on the label with a designation such as “manufactured for” or “distributed by.”
What are the labeling requirements?
Products must be labeled per the Act with the following:
- Declaration of identity.
- Declaration of responsibility (name and address of manufacturer, packer, or distributor)
- Declaration of net quantity, servings, or uses.
What is an investigational device exemption study?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
What is the purpose of Investigational Device Exemption?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA.
What is considered an investigational device?
An investigational medical device is one that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.
What is the difference between label and labeling?
As nouns the difference between label and labeling is that label is a small ticket or sign giving information about something to which it is attached or intended to be attached while labeling is a set of labels applied to the various objects in a system.
What are the legal requirements for package labels?
Products must be labeled per the Act with the following: Declaration of identity. Declaration of responsibility (name and address of manufacturer, packer, or distributor) Declaration of net quantity, servings, or uses.
What are the mandatory labels of every products?
All product labels must have the following four required statements:
- an identity statement.
- a net weight statement.
- a list of ingredients.
- company name and address.