21 cfr 820 FAQs

 

Important 21 cfr 820 Faqs 

• What 21 cfr 820? 

The 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. These CGMP requirements ensure medical device companies establish a QMS that enables the delivery of safe, effective, and compliant products. As stated by FDA, 21 CFR Part 820 covers “the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use,” including the facilities and designs used for those processes.

What are the FDA requirements of 21 CFR PART 820—quality system regulation?

• 21 CFR PART 820 QUALITY SYSTEM REQUIREMENTS

FDA conducts regular inspections to ensure compliance with its QSR. FDA uses the Quality System Inspection Technique (QSIT) to evaluate the alignment of internal quality system processes with regulatory requirements. The stakes of compliance are clear. Violations can result in 483 observations and warning letters. 

• 21 CFR PART 820—DOCUMENT CONTROLS

It covers document controls. Document control refers to policies and procedures quality managers use to manage documents throughout the medical device product lifecycle.

What are the FDA requirements of 21 CFR PART 820—quality system regulation?

• 21 CFR PART 820 QUALITY SYSTEM REQUIREMENTS

FDA conducts regular inspections to ensure compliance with its QSR. FDA uses the Quality System Inspection Technique (QSIT) to evaluate the alignment of internal quality system processes with regulatory requirements. The stakes of compliance are clear. Violations can result in 483 observations and warning letters. 

• 21 CFR PART 820—DOCUMENT CONTROLS

It covers document controls. Document control refers to policies and procedures quality managers use to manage documents throughout the medical device product lifecycle.

The FDA regulations apply to finished device manufacturers who distribute commercial medical devices. According to 21 CFR 820.3(l) a finished device is defined as “any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.” 

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