The Food and Drug Administration has released a new plan detailing 25 actions it plans to take in 2011 to improve the 510(k) approval process of medical devices, according to an FDA news release.
In Sept. 2009, the FDA's Center for Devices and Radiological Health created two internal working groups to address concerns that the 510(k) process was unpredictable, inconsistent, opaque and not robust enough. The two working groups issued 55 recommendations in Aug. 2010.
After reviewing input from the general public as well as industry members, healthcare professionals and other affected parties, CDRH announced 25 actions it plans to take in order to improve the 510(k) review process in 2011. Key actions include the following:
• 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.
CDRH is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision and is planning a public meeting in April for feedback on two other recommendations.
Read the news release about the 501(k) review process.
Read other coverage about FDA approval:
- B. Braun Announces FDA Approval of OTC Wound Management Gel
- FDA Warns Healthcare Professionals of Serious Adverse Events With Morphine Sulfate Oral Solutions
- 15 Spine Devices Receive FDA 510(k) Clearance in December
In Sept. 2009, the FDA's Center for Devices and Radiological Health created two internal working groups to address concerns that the 510(k) process was unpredictable, inconsistent, opaque and not robust enough. The two working groups issued 55 recommendations in Aug. 2010.
After reviewing input from the general public as well as industry members, healthcare professionals and other affected parties, CDRH announced 25 actions it plans to take in order to improve the 510(k) review process in 2011. Key actions include the following:
• 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.
CDRH is giving the Institute of Medicine an opportunity to provide feedback on seven recommendations before making a final decision and is planning a public meeting in April for feedback on two other recommendations.
Read the news release about the 501(k) review process.
Read other coverage about FDA approval:
- B. Braun Announces FDA Approval of OTC Wound Management Gel
- FDA Warns Healthcare Professionals of Serious Adverse Events With Morphine Sulfate Oral Solutions
- 15 Spine Devices Receive FDA 510(k) Clearance in December