There are two critical elements for governmental regulatory attention:
1. Product
2. Use of Product
The pre-market review focuses on the product control side of the equation, and post-market surveillance ensures that the devices in use continue to be safe and effective. However, there is an additional key element, which is the representation of the product to the user: labeling during the pre-market stage, and advertising of product.
Pre-market control is conducted to make sure that the product complies with regulatory requirements. Labeling and Advertisement control is maintained for correct product representation. However, in my experience working with medical device customers, the labeling process is typically very manual process supported by several home-grown or best of breed software systems. This makes the process inefficient, but most importantly prone to human error. If you search on FDA's recall website, in 2011 there are 87 recalls related to label/labeling issues. 3 of them are class 1 recalls by Medtronic.
In addition to product recalls, incorrect, inaccurate or incomplete label/labeling information can delay 501(k) approval process. FDA has clearly outlined what is required as part of pre-market approval process, such as instruction for use (IFU), etc. Typically, these IFU's are written towards the end of the project and have very small window to complete the required literature, such as complete instruction, maintenance instruction, cleaning/sterilization instructions, etc. to meet FDA requirements.
The best-practice will be to leverage an enterprise PLM system in conjunction with a Label management system to drive efficiency and lower "cost of compliance". The key will be to enable a process which leverages version controlled label templates with product content and workflow from a PLM system to deliver compliant labels on demand anywhere in the world.
1. Product
2. Use of Product
The pre-market review focuses on the product control side of the equation, and post-market surveillance ensures that the devices in use continue to be safe and effective. However, there is an additional key element, which is the representation of the product to the user: labeling during the pre-market stage, and advertising of product.
Pre-market control is conducted to make sure that the product complies with regulatory requirements. Labeling and Advertisement control is maintained for correct product representation. However, in my experience working with medical device customers, the labeling process is typically very manual process supported by several home-grown or best of breed software systems. This makes the process inefficient, but most importantly prone to human error. If you search on FDA's recall website, in 2011 there are 87 recalls related to label/labeling issues. 3 of them are class 1 recalls by Medtronic.
In addition to product recalls, incorrect, inaccurate or incomplete label/labeling information can delay 501(k) approval process. FDA has clearly outlined what is required as part of pre-market approval process, such as instruction for use (IFU), etc. Typically, these IFU's are written towards the end of the project and have very small window to complete the required literature, such as complete instruction, maintenance instruction, cleaning/sterilization instructions, etc. to meet FDA requirements.
The best-practice will be to leverage an enterprise PLM system in conjunction with a Label management system to drive efficiency and lower "cost of compliance". The key will be to enable a process which leverages version controlled label templates with product content and workflow from a PLM system to deliver compliant labels on demand anywhere in the world.
