01.19.11
Finally, the wait is over. After sitting through countless meetings (throughout the country, no less) and scouring dozens of comments from medical device industry representatives, the U.S. Food and Drug Administration on Wednesday unveiled 25 changes to its highly-criticized 510(k) program, promising to transform the procedure into a more transparent, efficient process.
The agency temporarily deferred its most controversial reforms, preferring to wait for the Institute of Medicine to release its own review of the 510(k) program this summer before making a final decision on their fate (the ability to revoke 510(k) clearances, requiring increased post-market surveillance and establishing a new device classification system that would require the submission of clinical data are among the most unpopular proposals).
Nevertheless, there are plenty of changes coming this year. To facilitate innovation in the medical technology industry, the CDRH plans to streamline the “de novo” process (typically reserved for innovative, lower-risk products) and publish guidance on product modifications and clinical trial data. The agency is hoping to deliver by September a 510(k) “paradigm” guidance that would include information on ways in which companies could use multiple predicates, the types of applications that would require clinical trial data, and a clear definition of “intended use.”
The CDRH also plans to develop a network of external experts to help the agency address scientific issues about new medical device technologies. In addition, the CDRH intends to create a new Center Science Council (CSC) to guide the agency in science-based decision making. Other changes to the 510(k) program include:
• Developing of unique product codes;
• Developing additional guidance on pre-IDE (investigational device exemption) meetings and enhancing the quality of pre-submission interactions between device companies and CDRH staff;
• Training new CDRH staff on core competencies, and improving knowledge management throughout the Center;
• Exploring the use of an “assurance case” framework for 510(k) submissions.
• Developing better data sources, methods and tools for collecting and analyzing postmarket information, and enhancing the CDRH’s capabilities to support evidence sythesis and quantitative decision making;
• Clarifying and more quickly informing companies and industry stakeholders about changes to the CDRH’s regulatory expectations;
• Assessing, characterizing and mitigating challenges in reviewing IDEs;
• Developing a process to regularly evaluate the list of device types eligible for third-party review and enhancing third-party reviewer training;
• Improving the recording of 510(k) transfers of ownership; and
• Clarifying the statutory listing requirements for submitting product labels.
Shuren said the 510(k) changes will lead to a “smarter” medical device program that supports innovation, retains jobs, and quickly brings safe and effective technologies to patients. “Facilitating innovation is a critical part of the agency’s responsibility to promote the public health, but this can happen only if the U.S. can support a robust, innovative medical device industry,” Shuren wrote in a letter that accompanied the 510(k) changes. “The steps we are announcing today remove roadblocks to innovation while protecting patient safety.”
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), called the FDA’s planned changes to its 510(k) program “a good first step” but noted that implementation of the plan will be critical.
“Much of the agency’s plan supports our long-standing position that the 510(k) process is fundamentally sound and has been beneficial to American patients. The plan also generally adheres to our principles that any changes to the 510(k) process should be targeted, have a corresponding health benefit and support timely access to new treatments and cures,” Ubl said in a prepared statement on his organization’s Website. “The plan will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process. The critical next step is how FDA implements the plan through guidances and regulations. Those details will determine whether today’s proposed changes will improve patient access and American competitiveness.”