FDA Roundup: July 25, 2023

FDA News Release

• For Immediate Release: July 25, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Monday, the FDA reopened the comment period for the 30-day procedural notice to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods” that appeared in the Federal Register on June 15, 2023. The new deadline for comments will be 11:59 PM on Wednesday, July 26, 2023.
• On Monday, the FDA recognized the following sterilization standards and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes. This latest update to the Recognized Consensus standards database is known as “List 60,” and includes:
  • new sterilization standards and reports:
    • ISO  22441:2022
    • AAMI  TIR104:2022
    •  AAMI  TIR17:2017/(R)2020
  • New versions of recognized standards
  • Revisions to some standards’ extent of recognition
  • Extended transition periods for two standards

The complete recognition of ISO 22441:2022, AAMI TIR104:2022, and AAMI TIR17:2017/(R)2020 is part of our ongoing efforts to advance innovation in medical device sterilization processes. It supports manufacturers’ use of low temperature vaporized hydrogen peroxide and provides more options for device sponsors to consider for submission during the premarket review process.

• On Friday, the FDA denied a petition requesting that the agency reconsider its denial of a citizen petition issued on May 19, 2022. The citizen petition requested a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five ortho-phthalates in food based on alleged safety concerns. Ortho-phthalates, often referred to as “phthalates,” are chemicals used in plastic products (most commonly in the specific type of plastic named polyvinyl chloride, also known as PVC or vinyl) to make the material soft and less brittle.
• On Friday, the FDA approved the Cordis Palmaz Mullins XD Pulmonary Stent for pediatric patients receiving treatment for pulmonary artery stenosis (PAS). PAS is a narrowing of a pulmonary artery, which is a serious form of congenital heart disease. The stent is placed in the pulmonary artery through a catheter inserted through the patient’s blood vessel. The stent addresses the critical narrowing of the pulmonary artery and keeps the pulmonary artery open, decreasing the pressure load on the right ventricle of the heart while improving blood flow to the lungs. This approval marks the first device of its kind approved to treat PAS in pediatric patients that offers an additional treatment option for patients. “This device approval is supported by real world evidence obtained from registry data,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “Real world evidence can help overcome some of the challenges presented when studying medical devices in pediatric populations. This approval is a great example of the use of real-world evidence to advance the care of pediatric patients.”