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Our company has compiled a traditional 510k submission for a class II medical device based on the FDA guidance on Format for Traditional and Abbreviated 510(k)s.
A consultant has looked at what we compiled and is telling us that all testing results must be included in the submission. Is this right? We currently indicate the standards we shall comply with as well as the 3rd party testing facilities that are conducting IEC and sterilization validations. Does the FDA require test results. We have 2 predicate devices we are claiming SE to.
A consultant has looked at what we compiled and is telling us that all testing results must be included in the submission. Is this right? We currently indicate the standards we shall comply with as well as the 3rd party testing facilities that are conducting IEC and sterilization validations. Does the FDA require test results. We have 2 predicate devices we are claiming SE to.