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We are a contract manufacturer of medical components. We are looking to:
1. Become an FDA registered Device Manufacturer
2. Submit a 510K application for a Class II device
The only reason for number 1 is so that number 2 can happen. I am estimating about 7 months on 510K approval. How long does it normally take to get registered as a Device Manufacturer? Is there a compliance audit? We are already ISO 9001 and ISO 13485 compliant.
1. Become an FDA registered Device Manufacturer
2. Submit a 510K application for a Class II device
The only reason for number 1 is so that number 2 can happen. I am estimating about 7 months on 510K approval. How long does it normally take to get registered as a Device Manufacturer? Is there a compliance audit? We are already ISO 9001 and ISO 13485 compliant.