The Baltimore Sun recently reported on an August 4th announcement made by the U.S. Food and Drug Administration (FDA) that may have a significant impact in the approval process for medical devices here in the United States:
Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.
The Food and Drug Administration released recommendations Tuesday night designed to improve oversight of the U.S. device industry, including the government’s ability to revoke approval for products that prove unsafe or ineffective.
The article discusses the recommendations, which came after “two internal FDA panels that were tapped to draft changes in the wake of the outside criticism.” Of course, there are both critics and supporters of the recently published information. The article provides a snapshot of each side of the issue:
“Taken together, these preliminary reports show a smarter FDA, an agency that recognizes both sides of our mission to protect and promote public health,” said FDA devices chief Dr. Jeffrey Shuren.
FDA’s critics said the recommendations are a positive first step, but that they hoped for bolder action from regulators.
“The good news is that I think the agency is admitting there are loopholes in the system that have allowed products to be sold that aren’t safe, the bad news is they haven’t yet figured out what to do about it,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families.
This being said, the FDA breaks down their assessment into three objectives, as listed in their announcement: the “three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.” In addition, recommendations are stated within each of the three objectives. These recommendations are also preliminary. The FDA announcement quotes a source, CDRH Director Jeffrey Shuren, M.D., as stating:
“Even with our significant outreach, it’s important to remember that these recommendations are preliminary,” said Shuren. “CDRH opened another public docket to receive additional comments on both reports. We will make a decision on which recommendations to adopt only after a thorough review of additional comments.”
It will be interesting to see what the comments are regarding these recommendations. We will continue to monitor developments and report as they become available.