Short introduction of USFDA Medical device regulatory affairs

1. By- Rohit
Medical Device Regulatory
(MDR)

2. Introduction
•Medical device’ means any instrument, apparatus, machine, appliance, implant,
reagent for in vitro reagent which is,
-Recognized in official national formulary and USP
-Intended to diagnose, prevent, cure, treatment and mitigation of disease
-Intended to affect the structure and function of the body
•Regulation is primarily concerned with enabling patient access to high quality, safe
and effective medical devices

3. Classification of MD (US-FDA)
 Medical devices are classified according to
-Degree of invasiveness
-Duration of use device (Short term or long term)
-Anatomical site (Surface or cavity)
Class-1 Medical Devices(MD)- They are at low risk. The examples are Bandage,
Tounge Depressor.
Class-2 MD- They are at moderate risk and the examples are contact lenses,
pregnancy test kit, catheter and needles.
Class-3 MD- It include higher risk and life sustaining devices. The examples are
Pacemaker, Stent and orthopedic implant

4.  For the The marketing of medical device into the different countries we need to
generate the safety and efficasy data of device.
 Different type of medical device require different procedure to follow for the
approval and marketing.
 Class 1 Devices-This required to follow the general control
-Registration and listing
-Medical device reporting
-Repair, replacement
-Records and reports
-Good manufacturing practices
 Class 2 Devices-Class 2 devices need to follow some special control in which we
have to demonstrate the substantial equivalence (Device is as safe and as
effective as previous)
 Substantial equivalence demonstrate by 510K application(Premarket Notification)
which further divided into traditional ,abbreviated (Use of guidance document or
confirm with recognize standard)and special 510k(Use design control aspect).

5. Characteristic of 510k
1)510k application generally submitted before 90 days of device marketing.
2)May not require clinical studies
3) Post market study not require
• Information to be submitted in 510K
- Performance of device in particular condition
- Information about design of devices
- Characterization of device component
- Representation of packaging and labeling data
- Description about quality of device
- Describe if any software or additional equipment needed
- Other admistrative form also require
- Risk assessment of medical device

6. Steps involve in 510k approval
Classify medical device (If class2)
Submit 510k application file
Comply QSR(21CFR820)
Appoint agent in US
Pay the fees and Registration with US-FDA

7. Regulatory requirements for class 3 MD
 Class 3 medical device require PMA(Pre-Market Approval) approval for
marketing.
 PMA is most stringent type of marketing application required by FDA for new
high risk devices.
 It require the clinical trial data and IDE(Allow and approve devices to be used
in clinical study to collect clinical data)
 Take 45 days to check whether it is admistratively correct or not and then 75
days to complete the initial review.
The Class 3 MD require the submission of following information
 Performance of device in particular condition
 Instruction of use
 Clinical trial data
 Design and Risk management
 Representation of packaging and labeling
 Information about computer software and literature about similar device and
disease

8. International Std for testing of MD
 ISO
 ASTM
 IEC
For class 2 and class 3 devices Design control, trials and Quality system
regulation is important for marketing of these devices.

9. Risk Management (ISO 14971)
Risk management involves the identification, understand, control, and
prevent failures that can result in hazards when people use medical
devices.

10.  Risk Analysis- Structured tool for the evaluation of potential problems which could
be encountered in connection with the use of taking a drug, or using a medical
device.
 Risk analysis is generally perform by Failure Mode and Effect Analysis (FMEA).
 FMEA is a step-by-step approach for identifying all possible failures in a design, a
manufacturing or assembly process, or a product or service.
 Risk Evaluation
Risk Analysis and Risk Evaluation
Severity x Occurrence x Detection = RPN

11. Risk control
• Re-designing of product and decrease the risk factor
• Use protective measures to decrease the chance of occurrence
• Add warning label regarding uses or handling

12. References
 https://www.wipro.com/en-IN/business-process/medical-devices/
 https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-
device-classification-and-reclassification
 WHO guidelines for medical device

13. THANK YOU…..