By Nick Otto
The FDA recently announced its intentions to add a new general training program component to its Experiential Learning Program (ELP).
The new program will help Center for Diagnostics and Radiological Health (CDRH) officials better understand “the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle,” such as biocompatibility testing and emerging manufacturing methods — like 3D printing.
In this training program, groups of CDRH officials will observe operations at research, manufacturing, academic, and healthcare facilities with a focus on, among other things:
- Biocompatibility testing: Officials will learn about the decision-making process for biocompatibility test selection.
- Combination products: CDRH staff will develop a better understanding of devices coated with a drug and drug delivery products.
- Emerging manufacturing methods: Officials will garner a better understanding of new methods like 3D printing, along with additional or unique validation and verification activities.
- Management of clinical trials for medical devices: The staff will develop a better understanding of clinical trial infrastructure and the roles, responsibilities, and relationships with other organizations involved in the management and conduct of clinical trials.
- Reprocessing and sterilization: Officials will learn about challenges in the manufacturing or clinical environment and unique sterilization methods — such as the use of flexible bags, sound waves, ultraviolet light, and microwave radiation.
The Regulatory Affairs Professional Society (RAPS) said that 3D printing has been a high priority topic in the agency’s quest for innovative manufacturing methods and notes that CDRH director Jeffrey Shuren has already alluded to a guidance on the subject to be released some time by the end of 2015.
Additionally, the FDA is planning a meeting on the subject to be held this October, according to RAPS.
The agency announced the launch of the ELP program in September 2011, with Shuren saying “we are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews."
CDRH also has interest in innovative manufacturing, training, and quality systems associated with in vivo diagnostics.
Requests to participate in the new training program are currently being accepted, and interested organizations should submit facility descriptions within areas of interest to docket no. FDA-2014-N-1088. In the announcement, the FDA added that officials attending are doing so as formal training visits, and the visits are not intended to “inspect, assess, judge, or perform a regulatory function.”
All others interested in providing comment should do so to the same docket number by Sept. 8.
Image Credit: “Printing with a 3D printer at Makers Party Bangalore.” Subhashish Panigrahi. 2013 CC BY-SA 3.0: http://creativecommons.org/licenses/by-sa/3.0/