The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
Timely compliance will ensure that your products will not be considered misbranded.
When applicable, the process provides novel products with a speedier route to market.
Penetrating the skin introduces a different set of unavoidable safety and efficacy questions.
When preparing a regulatory submission, there are a couple of critical elements to consider.