The medical device industry has generally expressed satisfaction with the Food & Drug Administration's move to revise the 510(k) device approval process, according to a Mass Device news report.
Companies that have expressed their opinions about the FDA 510(k) clearance process include the following:
• Susan Alpert, MD, senior vice president and chief regulatory officer at Medtronic, said she feels relieved and reassured about the new review process, including the passage of one controversial recommendation that would require companies to provide more data on devices for an Institute of Medicine committee's review.
• The California Healthcare Institute's CEO David Gollaher said, "CHI is pleased that the FDA has recognized its essential role in shaping the environment for biomedical innovation and the need for greater clarify and efficiency in its review processes."
• Medical Imaging & Technology Alliance shares a similar view, stating its approval of the FDA's move toward revising the device clearance process. "A clear, transparent, and timely 510(k) clearance process is critical to ensuring that Americans have access to the most advanced, life-saving medical technology innovations in the world," MITA Executive Director Dave Fisher said.
• Bob Schmidt, who founded several medical device companies including Cleveland Medical Devices and Orbital Research, however, demonstrated some concern over the proposed changes to the clearance process, saying new regulations that add expenses or lead to delays in introducing cost-saving medical devices to the market will actually increase healthcare costs.
Read the report about the medical device industry's reaction to the FDA's 510(k) process.
Read other coverage about FDA 510(k):
- FDA Announces 25 Actions to Improve Medical Device Approval Process
- Zyga Technology Receives FDA 510(k) Clearance for Sacroiliac Joint Fusion System
Companies that have expressed their opinions about the FDA 510(k) clearance process include the following:
• Susan Alpert, MD, senior vice president and chief regulatory officer at Medtronic, said she feels relieved and reassured about the new review process, including the passage of one controversial recommendation that would require companies to provide more data on devices for an Institute of Medicine committee's review.
• The California Healthcare Institute's CEO David Gollaher said, "CHI is pleased that the FDA has recognized its essential role in shaping the environment for biomedical innovation and the need for greater clarify and efficiency in its review processes."
• Medical Imaging & Technology Alliance shares a similar view, stating its approval of the FDA's move toward revising the device clearance process. "A clear, transparent, and timely 510(k) clearance process is critical to ensuring that Americans have access to the most advanced, life-saving medical technology innovations in the world," MITA Executive Director Dave Fisher said.
• Bob Schmidt, who founded several medical device companies including Cleveland Medical Devices and Orbital Research, however, demonstrated some concern over the proposed changes to the clearance process, saying new regulations that add expenses or lead to delays in introducing cost-saving medical devices to the market will actually increase healthcare costs.
Read the report about the medical device industry's reaction to the FDA's 510(k) process.
Read other coverage about FDA 510(k):
- FDA Announces 25 Actions to Improve Medical Device Approval Process
- Zyga Technology Receives FDA 510(k) Clearance for Sacroiliac Joint Fusion System