FDA QSR Compliance for Medical Device Manufacturers
Ensure your medical device meets FDA quality system requirements with expert guidance on QSR compliance and efficient implementation of 21 CFR Part 820.
Understanding FDA Quality System Regulation (QSR) 21 CFR Part 820
While most medical device regulators require manufacturers to maintain a quality management system (QMS), and typically this QMS is to be aligned with ISO 13485:2016, the US FDA has its own set of regulations: Quality System Regulation (QSR) 21 CFR Part 820, which outlines the Current Good Manufacturing Practices (cGMP) for medical devices and IVDs sold in the US. At present, the FDA’s Quality System Regulation (QSR) (Part 820) are a standalone set of requirements that have numerous similarities to ISO 13485:2016, and compliance is an FDA if you’re aiming for FDA clearance. In February 2026 FDA will introduce a significant update to the 21 CFR Part 820, which will include the obligation to meet the requirements of ISO 13485:2016, while scaling back most of the “FDA-specific” requirements that have historically made up 21 CFR Part 820.
What are the medical device QMS requirements in the US?
All Class III, Class II, and some Class I devices are required to have a QMS in place, including in most cases these devices must comply with “design controls”. Today the compliance requirements are embedded in 21 CFR Part 820; however, there is no certification requirement. However, manufacturers of Class III devices that are submitting a Premarket Approval (PMA) application will undergo a mandatory QMS inspection as part of FDA’s PMA review.
While there is not a certification process, FDA does reserve the right to conduct an inspection of your facility throughout the lifetime of your company to confirm compliance with FDA’s QSRs. For US-based manufacturers this inspection can be unannounced. Compliance issues identified during the FDA inspection can result in the issuance of an FDA Form 483, or “Notice of Inspectional Observations,” or in some circumstances a FDA Warning Letter, which is a publicly available compliance report. In either case, receiving a Form 483 or a Warning Letter can be a disruptive and expensive outcome of the inspection.
As mentioned above, FDA has set a release date of 2 February 2026 for their new quality system requirements, which have been rebranded as the QMSR (Quality Management System Regulations). The QMSR will rely upon ISO 13485:2016 with the addition of a few FDA-specific requirements; however, FDA will not require manufacturers to be certified to ISO 13485:2016, thus self-declaration of compliance to ISO 13485:2016 will be sufficient.
NOTE: Although FDA does not expect manufacturers to obtain certification to ISO 13485:2016, this is a requirement of many global regulatory authorities.
If you are just starting to develop your quality management system, this can be a daunting experience, one that can be even more challenging given the FDA’s transition to ISO 13485:2016. Opting to work an experienced quality consultant can help reduce the possibilities of compliance problems and project delays.
Navigating FDA QSR Requirements
Our expert team at MedEnvoy has decades of experience implementing and auditing quality management systems for medical device and IVD manufacturers. Whether you’re starting from scratch, updating your existing system to comply with upcoming changes to FDA’s quality system regulations, or you need help bringing your QMS back into compliance after an inspection, we can help you navigate FDA’s requirements.
How we can help:
FDA QSR Compliance Assessments
Our team conducts a thorough assessment of your current quality management system, processes, and documentation to identify areas of non-compliance and potential improvements.
Documentation and Training
We assist in the development and optimization of essential documentation, as well as train your team with the knowledge and skills necessary to maintain your documents and procedures.
Post-Implementation Support
We offer ongoing support to address any challenges, updates, or changes in regulations, ensuring that your organization remains compliant in the long run.
Customized QMS Implementation Roadmap
Based on the assessment results, we develop tailored implementation plans that outline the steps required to achieve and maintain compliance with FDA QSR and the future QMSR.
Audits and Inspections Preparation
Our consultants prepare your organization for FDA inspections, ensuring that you are well-equipped to demonstrate compliance and respond effectively to regulatory inquiries.
