FDA Announces 510(k) Changes (HealthPointCapital)
FDA to improve most common review path for medical devices (FDA)
510(K) AND SCIENCE REPORT RECOMMENDATIONS: SUMMARY AND OVERVIEW OF COMMENTS AND NEXT STEPS (FDA)
FDA will implement 25 actions during 2011 to improve the 510(k) review process for medical devices. Key actions include:
- Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,
- Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process,
- Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.