Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
MedTech Exec Talk
Regulatory, Quality and Good Manufacturing Practices
FDA is taking steps to make it flexible and efficient for developers of lower-risk devices to get their products to market swiftly. To accomplish this, FDA sees the 510(k) Third Party Review Program playing a crucial role. FDA is enhancing the program with the goal of obtaining FDA-equivalent review results from third party review organizations while reducing the amount of time FDA spends re-reviewing applications that have already been reviewed by third party organizations. This frees FDA resources to focus on those higher-risk devices that require more rigorous review. In the first year of MDUFA IV, FDA has already made considerable headway to strengthen the program, including sharing a plan to enhance the program, releasing a draft guidance, developing training for third party reviewers and undertaking process improvement activities. In this session, FDA will take a deep dive into the progress made to strengthen the program. Strengthening the 510(k) Third Party Review Program will make the third party review process what it was meant to be: a means of streamlining the regulatory process while maximizing patient benefit. FDA believes this approach will lessen burden on 510(k) applicants and FDA reviewers while ensuring that medical devices continue to meet high standards for safety and effectiveness.