ASTRO: Safeguards needed to ensure new devices, in step with FDA
In a statement responding to the FDA’s letter to radiation equipment manufacturers announcing it was taking steps to strengthen the approval process for radiotherapy devices, the American Society for Radiation Oncology Chairman Tim Williams said the organization “support[s] the retention of the 510(k) clearance process, but urge[s] that appropriate safeguards be implemented to ensure that new technology is safe and effective.
The FDA letter, which was sent last week, detailed the number of reports of errors involving radiation devices it has received over the last 10 years and said that the agency may no longer allow the use of third-party review in order to streamline the approval process.
“ASTRO also agrees that quality concerns with the third-party review program should be addressed and that the FDA must ensure that third party reviewers have not only the appropriate expertise, but also the necessary information to conduct a thorough review,” said Williams.
The FDA letter, which was sent last week, detailed the number of reports of errors involving radiation devices it has received over the last 10 years and said that the agency may no longer allow the use of third-party review in order to streamline the approval process.
“ASTRO also agrees that quality concerns with the third-party review program should be addressed and that the FDA must ensure that third party reviewers have not only the appropriate expertise, but also the necessary information to conduct a thorough review,” said Williams.