FDA QSR (21 CFR 820) for Medical Device Manufacturers

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. This is important for manufacturers to ensure they are producing medical devices which are effective and assure patient safety.

This regulation is a requirement for all medical device manufacturers. Being subject to inspection from the FDA, non-compliance or being found to fall short of the minimum standards will result in receiving a warning letter which will also be publicly shared on the FDA website.

Currently, the FDA is working towards replacing parts of the existing Quality System Regulation (QSR 21 CFR 820), with the international standard ISO 13485:2016.

Who needs to comply with the FDA QSR?

If your company manufactures a medical device or in vitro diagnostic (IVD), you are probably required to implement a quality management system that is compliant with 21 CFR Part 820. If you are responsible for the design and post-market activities of the device, the FDA considers you a “manufacturer” even if you outsource all of your manufacturing activities. Therefore, most companies marketing a medical device or IVD must implement a QSR-compliant system.

How the FDA enforces compliance with QSR

Even though the FDA will not require a pre-registration audit, you are required by law to be in compliance with applicable sections of the QSR before placing your device on the market. If the FDA visits your facility for an inspection and finds the facility not in compliance, they may issue a Form 483. You must conduct internal audits of your quality management system to ensure it is in compliance.

Why choose QSG for your 21 CFR Part 820 compliance projects?

As an experienced medical device regulatory consulting firm, QSG has implemented many 21 CFR Part 820 and ISO 13485 compliant quality management systems for medical device and IVD manufacturers in North America, Europe, and Asia. Here’s how we can help:

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