Minnesota Senator Amy Klobuchar and 40 other legislators wrote a letter to FDA head Margaret Hamburg to ask for a more efficient medical device review process, according to a Mass Device report.
Sen. Klobucher is the co-chair of the Congressional Technology Caucus. The letter suggested four areas for improvement:
1. Recognizing and correcting the disparity between "FDA time" versus real time when tracking device approvals
2. Considering potential benefits of harmonization with international testing standards
3. Addressing the unintended consequences of the conflict of interest rules for advisory panels
4. Creating a transparent tracking and review system for applications and clearance decisions
Related Articles on the FDA:
John Stossel: The FDA is Killing Us
FDA Extends Comment Period on 510(k) Document
FDA Launches Website on Safe Disposal of Used Needles and Other "Sharps"
Sen. Klobucher is the co-chair of the Congressional Technology Caucus. The letter suggested four areas for improvement:
1. Recognizing and correcting the disparity between "FDA time" versus real time when tracking device approvals
2. Considering potential benefits of harmonization with international testing standards
3. Addressing the unintended consequences of the conflict of interest rules for advisory panels
4. Creating a transparent tracking and review system for applications and clearance decisions
Related Articles on the FDA:
John Stossel: The FDA is Killing Us
FDA Extends Comment Period on 510(k) Document
FDA Launches Website on Safe Disposal of Used Needles and Other "Sharps"