In-vitro diagnostic regulation overview as per FDA , including in-vitro defination , classification , examples , general control, special control , pre market notification , DeNovo classification , PMA , 510k or premarket notification , risk based classification

1. In-vitro diagnostics
Presented By:
Richa Trivedi
Roll no 10
MRA SEM II

2. What is an in vitro diagnostics?
• IVDs are those reagents, instruments, and systems
intended for use in diagnosis of disease or other
conditions
• It also includs a determination of the state of health, in
order to cure, mitigate, treat, or prevent disease or its
sequelae
• Intended for use in the collection, preparation, and
examination of specimens taken from the human body

3. Classification of IVDs
• The FDA classifies IVD products according to the
level of regulatory control that is necessary to
reasonably assure safety and effectiveness
Mainly divided into three classes
• Class I (low to moderate risk): general controls
• Class II (moderate to high risk): general controls and
Special Controls
• Class III (high risk): general controls and Premarket
Approval (PMA)

4. • Class I – IVDs typically present low risk(s) to the user or patient when used to make medical decisions
• Premarket submissions are not required for class I exempt devices. However, a manufacturer must
submit a premarket notification for class I devices that are not exempt
• Exemption generally means that a premarket notification is not necessary to provide a reasonable
assurance of safety and effectiveness and that the other general controls are sufficient to provide
such as reasonable assurance. Examples of exempt devices are manual stethoscopes, mercury
thermometers and bedpans
• Examples include enema kits and elastic bandages
• 47% of medical devices fall under this category and 95% of these are exempt from the regulatory
process

5. • Class II – IVDs are those devices that have a moderate to high risk to the patient and/or user
• Most medical devices are considered Class II devices. 43% of medical devices fall under this
category
• Examples of Class II devices include powered wheelchairs and some pregnancy test kits
• Class III – These devices usually sustain or support life, are implanted, or present potential
unreasonable risk of illness or injury
• Examples of Class III devices include implantable pacemakers and breast implants
• 10% of medical devices fall under this category

6. General Control
• IVDs are subject to General Controls, unless expressly exempt per the statute or regulations
General Controls include the provisions of the Act pertaining to:
• Adulteration
• Misbranding
• Device registration and listing
• Premarket notification
• Banned devices
• Notification and repair, replacement, and refund
• Records and reports
• Restricted devices
• Good Manufacturing Practices

7. Special Control
• FDA classifies into class II devices for which general controls alone are insufficient to provide reasonable
assurance of the safety and effectiveness of the device, and for which there is sufficient information to
establish special controls to provide such assurance
Special controls are usually device-specific and include:
• Performance standards
• Postmarket surveillance
• Patient registries
• Special labeling requirements
• Premarket data requirements
• Guidelines

8. Premarket Notification 510(k)
• A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at
least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not
subject to premarket approval (PMA)
There are three types of Premarket Notification 510(k)s that may be submitted to the FDA:
• Traditional,
• Special, and
• Abbreviated

9. De Novo Classification of IVDs
• The De Novo process provides a pathway to classify novel medical devices for which general
controls alone, or general and special controls, provide reasonable assurance of safety and
effectiveness for the intended use, but for which there is no legally marketed predicate device. De
Novo classification is a risk-based classification process
• Devices that are classified into class I or class II through a De Novo Classification Request (De Novo
request) may be marketed and used as predicates for future premarket notification [510(k)]
submissions

10. Premarket Approval (PMA)
• Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the
safety and effectiveness of Class III medical devices
• PMA is the most stringent type of device marketing application required by FDA
• The applicant must receive FDA approval of its PMA application prior to marketing the device
• PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific
evidence to assure that the device is safe and effective for its intended use
• The PMA applicant is usually the person who owns the rights, or otherwise has authorized access,
to the data and other information to be submitted in support of FDA approval. The applicant is
often the inventor/developer and ultimately the manufacturer.

11. References:
USFDA official website
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation