Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi, 

I bet this has been asked here before but I couldn't locate it so here it is. 

The FDA considers adult population to be >=22 years (including the 22nd birthday); however, in many other countries around the world the definition of adults is >18 years. 

I can think of two ways: 1) Take the 22yo definition globally for the product - this is certainly restrictive. 2) Create region specific definitions and have DHF documentation and labelling to support each - this is ideal but requires double handling in certain respects. 

What are some other ways in which this can be handled within the DHF (incl risk management file) and also areas like labelling where age is provided as contraindication?

In the DHF, when defining age ranges for the adult population, it is essential to be consistent with the regulatory requirements of the specific market where the medical device will be marketed. Clearly specify the age ranges based on the applicable regulations for each target market.

Risk management file: In the risk management file, consider including a comprehensive analysis of the potential risks associated with the use of the device in different age groups. Identify and assess specific risks related to the age of the patients, taking into account both the FDA's definition of adult population (>=22 years) and the definitions used in other countries (>18 years). Ensure that the risk management activities address the potential hazards for each relevant age group.

Labeling considerations: In the labeling, it's important to adhere to the specific labeling requirements of each regulatory authority. When age is provided as a contraindication, consider the following:

a. Dual labeling: If feasible and allowed by the regulatory authorities, consider dual labeling to accommodate the different age definitions. This would involve specifying the contraindication based on both the FDA's definition (>=22 years) and the definitions used in other countries (>18 years).

b. Country-specific labeling: If dual labeling is not feasible, ensure that the labeling aligns with the requirements of each specific country. Modify the labeling for different markets to reflect the appropriate age contraindication based on the regulatory guidelines in each country.

c. Risk-based language: Consider using risk-based language in the labeling, emphasizing the specific risks associated with different age groups rather than relying solely on age as a contraindication. This approach can provide more context and allow healthcare professionals to make informed decisions based on the patient's individual circumstances.

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 14-May-2023 18:32
From: Anonymous Member
Subject: Definition of adult population: US vs ROW

This message was posted by a user wishing to remain anonymous

Hi,

I bet this has been asked here before but I couldn't locate it so here it is.

The FDA considers adult population to be >=22 years (including the 22nd birthday); however, in many other countries around the world the definition of adults is >18 years.

I can think of two ways: 1) Take the 22yo definition globally for the product - this is certainly restrictive. 2) Create region specific definitions and have DHF documentation and labelling to support each - this is ideal but requires double handling in certain respects.

What are some other ways in which this can be handled within the DHF (incl risk management file) and also areas like labelling where age is provided as contraindication?

Anon,

In my experience the two options you presented are probably the only ones available; I am not sure of a mixed-way this could be done.  The first pathway is probably the easiest approach, though may limit your marketing group and labelling from penetration in different markets.  So then the second pathway would be having different Instructions for Use (IFU) or labelling which would identify the different patient age groups.  I worked for a couple organisations where we had a US label and a ROW label.  There was not really a way we could mix the two because the devices we had were patient age dependent and the FDA is quite clear on "adult" age and from 10 years ago are wanting this specified in submissions.  So unfortunately, if the different regions you are looking at require specific labelling, yes it will be administrative difficult to manage potential multiple versions of the device labelling.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 16-May-2023 11:05
From: Rajeswari Devanathan
Subject: Definition of adult population: US vs ROW

In the DHF, when defining age ranges for the adult population, it is essential to be consistent with the regulatory requirements of the specific market where the medical device will be marketed. Clearly specify the age ranges based on the applicable regulations for each target market.

Risk management file: In the risk management file, consider including a comprehensive analysis of the potential risks associated with the use of the device in different age groups. Identify and assess specific risks related to the age of the patients, taking into account both the FDA's definition of adult population (>=22 years) and the definitions used in other countries (>18 years). Ensure that the risk management activities address the potential hazards for each relevant age group.

Labeling considerations: In the labeling, it's important to adhere to the specific labeling requirements of each regulatory authority. When age is provided as a contraindication, consider the following:

a. Dual labeling: If feasible and allowed by the regulatory authorities, consider dual labeling to accommodate the different age definitions. This would involve specifying the contraindication based on both the FDA's definition (>=22 years) and the definitions used in other countries (>18 years).

b. Country-specific labeling: If dual labeling is not feasible, ensure that the labeling aligns with the requirements of each specific country. Modify the labeling for different markets to reflect the appropriate age contraindication based on the regulatory guidelines in each country.

c. Risk-based language: Consider using risk-based language in the labeling, emphasizing the specific risks associated with different age groups rather than relying solely on age as a contraindication. This approach can provide more context and allow healthcare professionals to make informed decisions based on the patient's individual circumstances.

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 14-May-2023 18:32
From: Anonymous Member
Subject: Definition of adult population: US vs ROW

This message was posted by a user wishing to remain anonymous

Hi,

I bet this has been asked here before but I couldn't locate it so here it is.

The FDA considers adult population to be >=22 years (including the 22nd birthday); however, in many other countries around the world the definition of adults is >18 years.

I can think of two ways: 1) Take the 22yo definition globally for the product - this is certainly restrictive. 2) Create region specific definitions and have DHF documentation and labelling to support each - this is ideal but requires double handling in certain respects.

What are some other ways in which this can be handled within the DHF (incl risk management file) and also areas like labelling where age is provided as contraindication?