what is the difference between iso 13485 and 21 cfr 820?

For the USA market, ISO 13485:2016 is not a regulation or law, however, while FDA 21 CFR Part 820 is mandatory for medical device distribution in the United States. The classification procedure and market approval processes are fully explained in the 21 CFR Part 860 (Code of Federal Regulations for Medical Device Classification Procedures). FDA QSR 21 CFR PART 820 ' ISO 13485:2016 1 Scope 2 Normative References 4.2.1 General 4.2.2 Quality Manual 4. Class I devices that are not listed as exempted devices undergo a Premarket Notification application with the FDA.

These Class I devices are under the fewest regulatory controls. 4.1.2 Quality Management System 820.5 Quality system Although 21 CFR 820. But, the supplier is mandated to register its institution and submit a list of generic products to the FDA. ISO 13485:2016 21 CFR 820 SPECIFIC DIFFERENCES 1 Scope 820.1 Scope 4.1.1 Quality management system, General requirements 820.5 Quality system No significant difference in requirements. Within Class I, if a device is classified into a general category of exempted devices, then no Premarket Notification application or FDA clearance is needed before selling the device in the U.S. FDA Inspections vs ISO Audits : FDA 21 CFR Part 820 and ISO 13485 FebruFDA Inspections And ISO Audits.

What is the difference between iso 13485 and 21 cfr 820?