How do I show compliance to 21CFR820?

ISO 13485 is a certificate which is issued by certifications bodies to manufacturer upon audit if the meet the ISO 13485 requirements But 21CFR820 is a regulation, how do I show compliance when my device is a class II (which has many predicates and is substantially equivalent)? Meaning, in this case I submit the eSTAR to FDA as part of 510k submission, but I dont need to show evidence of 21CFR820 neither FDA audits me prior to submission like Europe. Then how do FDA check if I am 21CFR820 compliance?

The 510(k) is focused on the safety and effectiveness of the device. Once cleared the FDA will audit onsite or remote to verify the GMP parts of the regulation. Having 13485 goes a long way but Part 11 and software tool validation is important

FDA always audits CAPA and complaints during an audit plus 1 more function. It could be design. production, suppliers etc.

If you pass a 13485 audit that will give you a perspective on what else is needed.

Ed Panek said:

The 510(k) is focused on the safety and effectiveness of the device. Once cleared the FDA will audit onsite or remote to verify the GMP parts of the regulation. Having 13485 goes a long way but Part 11 and software tool validation is important

FDA always audits CAPA and complaints during an audit plus 1 more function. It could be design. production, suppliers etc.

If you pass a 13485 audit that will give you a perspective on what else is needed.

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Is it always that FDA audits after 510k clearance? What is the timeframe of audit after the clearance?

Expect a visit within 24 months. There are exceptions: For cause audit based on a complaint or even if there is a rash of complaints in a type of device FDA may audit ALL manufacturers of that type of device.