What is 21 CFR Part 820?
21 CFR Part 820 is FDA’s Quality System Regulation (QSR) on how to manage a Medical Device’s Quality Management System. It outlines the recommendations which eventually will lead to a safe and effective device.
As the medical device world is extremely diverse, the 21 CFR Part 820 schematically outlines the requirements of the design, development, production, distribution etc. processes, but it is up to the manufacturer to determine which elements are relevant to its device and respectively implement those in the manufacturing process.
Comparison: 21 CFR Part 820 vs. ISO 13485:2016
ISO 13485 is an international standard which represents the requirements for a Quality Management System for companies which design and manufacture of Medical Devices. The requirements of the ISO 13485 and the QSR differ slightly and compliance with one does not automatically infer compliance with the other.
A Medical Device manufacturer pursuing both the US and the European markets will need to establish a QMS that meets the requirements of both the ISO 13485 and the QSR.
So what is the difference between the two?
|Topic||ISO 13485:2016||FDA 21 CFR Part 820|
|Legal status||Has no legal basis, however has a worldwide recognition||Has a legal status and is mandatory for Medical Devices distributed in the US|
|Distribution||An international standard used by many states||Applies only in the US but is also acknowledged by other countries as well.|
|Outside influence||A certification is issued by an external accredited body||No certification|
|Audits||Annual surveillance audits, renewal audit every 3 years||Class II and Class III device manufacturers are inspected every two years|
How can we help?
Since 2007 Li-Med’s, experts have been assisting Medical Device companies establish and maintain their QMS based on the 21 CFR Part 820 and ISO 13485 requirements. The process that we establish applies the rules and regulations that help maintain the Plan-Do-Check-Act (PDCA) cycle and keep in accordance with the latest version.
In addition to internal audits that we perform, we have a team of professional medical device experts with experience in quality standards and regulatory compliance who can help you prepare for any audit.