ISO 13485 is a global standard that is voluntary in the US but required in some countries. ISO 13485 will become the FDA’s mandatory QMS April of 2019. ... 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including imported products.
What is 21 CFR Part 820 and why should you care?
What is 21 CFR Part 820 and why should you care? 21 CFR Part 820 is part of the Current Good Manufacturing Practice (CGMP) regulations . It ensures that all medical devices created and developed within the US market are safe and follow satisfactory quality processes at all stages of development.
What is FDA CFR 21 Part 820?
21 CFR Part 820 is a set of regulations from FDA that outlines the current good manufacturing practice (CGMP) requirements that medical device manufacturers in the United States must follow with regards to their quality system .
Which standard will the FDA use to replace 21 CFR Part 820 in 2020?
FDA has formally announced its intention to transition away from the Quality Systems Regulation (QSR) per 21 CFR 820 and transition to the ISO 13485:2016 for its audit inspections of medical device manufacturers. The new rule could be released as soon as mid 2019 and will roll out over the next few years.
What is the difference between ISO 13485 and EN ISO 13485?
With respect to ISO 13485:2016, there is no difference in the main text between EN ISO 13485 and ISO 13485. The only difference is the addition of the Z annexes. So, if you have ISO 13485, and can preview the Z-annexes (at link above, or through iso/bsi, etc. webstores), you don’t need to purchase the EN version.
Is ISO 13485 mandatory?
The short answer is no, ISO 13485 is not mandatory . You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them.
Who does QSR apply to?
The QSR applies to manufacturers in the United States and is created and managed by the FDA, while the ISO 13485 is a standard in the GMS which is used internationally. ISO 13485 is a voluntary standard, while the QSR is a mandatory regulation.
What does CFR stand for?
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
What is meant by 21 CFR?
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration .
What does Title 21 of CFR describe?
Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy).
Does the FDA use ISO 13485?
Management systems
The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation .
What is a CGMP facility?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA . CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
What is ISO 13485?
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services . It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Who needs ISO 13485 certification?
Any company involved in the supply chain of medical devices needs ISO 13485 certification. This is particularly true for those that design, develop, manufacture, and distribute these types of products. Even local regulations in various countries require businesses to gain certification.
What does ISO 13485 require?
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Why is ISO 13485 important?
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
