The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates.
The ELP Program
FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manufacturers.
The program, officially launched in April 2013, works by allowing FDA officials to attend "formal training visits" at industry sites. Companies choose to cooperate with FDA on a voluntary basis, FDA confirmed, and the visits are not intended to "inspect, assess, judge, or perform a regulatory function," FDA said.
In a September 2011 statement announcing the launch of the program, CDRH Director Jeffery Shuren said the ELP would "help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care."
“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,” said Shuren. “This investment will improve the quality of submission review and make the process more consistent and predictable.”
To date, FDA has identified several dozen areas of interest, ranging from the manufacture of companion diagnostics to the operation of clinical testing in CLIA high-complexity laboratories.
But while FDA has already moved to extend the program once ( in May 2014), it is now announcing that it plans to expand it as well.
In a 7 August 2014 Federal Register announcement, FDA said that it plans to launch a "new component" of the ELP in the hopes of providing CDRH staff with "the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle."
The new component will be known as the "ELP General Training Program," and is intended to "enhance communication and facilitate the premarket review process."
As with the broader ELP program, FDA said its General Training Program will focus on several "areas of interest," which are expected to change as the program evolves.
The list is currently as follows:
|Office of Device Evaluation|
|Biocompatibility testing||Decisionmaking process for biocompatibility test selection; considerations for use of animal testing vs. in vitro testing; sample preparation of nanoscale, bioabsorbable, and in situ polymerized materials; evaluation of color additives.|
|Combination products||Devices coated with drug(s); drug delivery products.|
|Emerging manufacturing methods||3-D printing; additive manufacturing; additional or unique validation and verification activities.|
|Management of clinical trials for medical devices||Understanding clinical trial infrastructure, roles, responsibilities, and relationships with other organizations involved in the management and conduct of clinical trials; challenges encountered in obtaining regulatory approval and successfully executing a clinical trial; issues related to early feasibility studies; institutional review boards; clinical research organizations.|
|Reprocessing and sterilization||Reprocessing challenges in the manufacturing or clinical environment; validation of reprocessing or sterilization instructions; simulated use testing; unique sterilization methods (e.g., use of flexible bags, sound waves, ultraviolet light, microwave radiation.)|
|Office of In Vitro Diagnostic Devices and Radiological Health|
|Manufacturing of in vitro diagnostic devices||Preanalytical devices (i.e. blood tubes), pathogen collection devices, micro collection/transport devices; general reagents, manual reagents; general assays, common point-of-care devices.|
|Instrument training of medical devices (manufacturer or clinical laboratory)||Hands-on instrument and system training; clinical implication of common laboratory testing.|
|Quality system in manufacturing environments||Observation of implemented quality systems practices based on current good manufacturing practices.|
Notably, FDA says it wants to assess 3-D printing technologies as part of its focus on "emerging manufacturing methods." Shuren has already indicated that a 3D printing guidance is due to be released by the end of 2015, and FDA has planned a meeting on the subject to be held in October 2014.
Federal Register Notice