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21 CFR, Part 820

21 CFR 820

For medical device manufacturers working to ISO 13485, the requirements of Title 21 CFR Part 820 will be familiar as both sets of standards are similar. However, there is a risk of creating a false sense of security when seeking approval for the US market, as EN ISO 13485 is not recognised as evidence of Title 21 CFR Part 820. Below is some important information on the requirements under Title 21 CFR Part 820.

According to Title 21 CFR Part 820, a quality management system (QMS) with corresponding documentation and implementation is required, for example in the areas of

  • Production
  • Procurement
  • Document control and
  • Development

It is important that the documentation demonstrates that the procedures described in Title 21 CFR Part 820 have been followed.

Since the requirements in certain areas such as design controls are formulated in quite general terms, the FDA's guidance documents should also be consulted.

In what cases must what be complied with?

Compliance with the regulations depends on the classification of the medical device. In principle, the "General Controls" (§501ff) laid down in the Food, Drug & Cosmetic Act apply. These already include requirements for Good Manufacturing Practice (GMP), which extend from the development to the installation of the devices. If the device is a Class II or higher medical device, the "Special Controls" also apply.

So, what are the differences between Title 21 CFR Part 820 and EN ISO 13485 if they are similar, but the latter is not recognised by the FDA as proof of compliance for the former?

  • EN ISO 13485 exceeds the requirements of Title 21 CFR Part 820 in terms of continuous improvement of the QM system and customer satisfaction.
  • On the other hand, the documentation requirements in Title 21 CFR Part 820 are more extensive.
  • Title 21 CFR Part 820 divides the documents into Design History File, Device Master Record and Device History Record.
  • There are serious differences regarding complaints and the reporting system.

As experienced consultants for medical device manufacturers, we can help you find your way into the US market. Do not hesitate to contact us for support and advice.

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