New Medical Device Training Program Intends to Help FDA Learn How Industry Operates
Nearly a year and a half after first announcing an experimental pilot program that would allow its medical device review staff to better understand how the regulatory process occurs from the perspective of industry, the US Food and Drug Administration (FDA) is finally looking to get the program fully up and running.
Background
The program was announced in September 2011, part of an ongoing effort for reforms at the Center for Devices and Radiological Health intended to accommodate criticism from industry. While far from uniform, some in industry have long complained that reviewers aren't always in tune with the realities of regulatory affairs from an industry perspective, and that some long-time FDA staff have little idea how industry manufactures its products.
Whether or not those criticisms have merit, FDA's program seems geared toward at least acknowledging those concerns, if not trying to mitigate them in their entirety.
"Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices," CDRH Director Jeffery Shuren said in a September 2011 statement on the program.
"The program will also help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care," FDA added.
"CDRH is committed to understanding current industry practices, innovative technologies, and regulatory impacts and needs," it said in yet another statement.
The program made its way into the agency's January 2012 strategic priorities list, in which it said that the program should be ready to exit the pilot stage and be fully implemented by the end of 2012.
FDA to Industry: Help us Learn about How You Operate
While that end-of-2012 goal seems to have been missed by a few months, FDA announced in the 2 April 2013 edition of the Federal Register that it is now ready to begin accepting voluntary enrollment into the program by industry, which would have to make its facilities available to FDA for use.
"These formal training visits are not a mechanism for FDA to inspect, assess, judge, or perform a regulatory function (i.e., compliance inspection), but rather, are an opportunity to provide the CDRH review staff a better understanding of the products they review," the agency said in the Register posting. "CDRH is formally requesting participation from companies, academia, and clinical facilities."
FDA's points of interest are largely outside of more routinized manufacturing processes, such as cGMP considerations for normal devices. Instead, it said, it's looking at niche cases where its staff might not otherwise be able to learn without direct observation or discussions.
FDA said that it will assume all travel expenses for the site visits, and that the sites must have a "satisfactory compliance history."
Areas of Interest
FDA identified 27 focus areas of interest, including specific sub-areas it wishes to learn more about.
Topic Area | Details |
Manufacturing and development of molecular/immunology devices | Molecular diagnostics devices and companion diagnostics devices. |
Manufacturing, development, and assessment of cytology/pathology devices | Semiautomated cytology screening devices; cytology collection devices use in human papillomavirus tests; immunohistochemistry tests development in clinical trials. |
Manufacturing of microbiology devices | Antimicrobial susceptibility devices. |
Manufacturing of chemistry devices | Clinical Laboratory Improvement Amendments (CLIA) waived devices, blood collection tubes, fecal occult blood devices. |
Manufacturing and development of hematology devices | Hematology analyzers (specific interest in new technology). |
Manufacturing and development of coagulation devices | Coagulation assays and controls, platelet aggregatometers devices, prothrombin time/international normalized ratio meters and assays, D-Dimer analyzers and assays. |
Observation of clinical testing in a CLIA high complexity laboratory | Observation of testing in a clinical testing environment. |
Performance validation and reliability testing of intensive care unit ventilator and anesthesia gas machines | Ventilators, continuous positive airway pressure devices, anesthesia gas machines, and closed-loop ventilators. |
Implantation techniques for spinal devices | Implantation training and assessment using cadavers and direct observation of surgical procedures for spinal implants including, but not limited to, lateral intervertebral body fusion devices, minimally invasive pedicle screw systems, and spinous process plates. |
Manufacturing of ultra-high molecular weight polyethylene device components | All joint replacement devices. |
Clinical use of orthopedic bone void filler devices | Observation of surgical procedures (posterolateral spine fusion, foot, ankle) utilizing bone void fillers. |
Reprocessing methods and techniques in the clinical environment | Cleaning and sterilization methods and techniques for endoscopes (including colonoscopes, duodenoscopes, cystoscopes, etc.) and accessories; automatic endoscope reprocessors. |
Bariatric surgery | Observation of bariatric surgical techniques, with and without bariatric devices. |
Manufacturing and assessment of hemodialyzers and filters | Hemodialyzers, hemofilters, hemoconcentrators, ultrafilters, and plasma filters. |
Sourcing and manufacturing of animal-derived collagen | Surgical meshes, wound dressings. |
Traumatic wound care, management, and treatment | Observation of clinical uses of wound management/treatment devices and hemostatic products for use on traumatic injuries. |
Clinical use of plastic and reconstructive devices | Observation of surgical procedures utilizing surgical meshes, dermal fillers, hemostatic agents, and bone waxes. |
Treatment of acute ischemic stroke | Clot retrieval procedures, clot retrieval devices and ancillary products (medications, angiograms), stroke centers, and acute stroke care programs. |
Clinical use of neurosurgical monitoring devices | Neuro-evoked response devices that are used for real-time monitoring of patients undergoing a back procedure. |
Clinical use of rehabilitation devices | Clinical use of physical medicine devices (prostheses, pressure-relieving seat cushions, tilt-in-space wheelchairs, and devices for pain relief) in a rehabilitation center setting for treatment of various conditions (e.g., spinal cord injuries, traumatic brain injuries, and amputations). |
Clinical use of cardiovascular devices | Endovascular stent grafts and associated delivery systems; Stents and associated delivery systems. |
Manufacturing of cardiovascular devices | Drug coated devices (e.g., stents and balloons), endovascular stent grafts and associated delivery systems, stents and associated delivery systems, percutaneous heart valves. |
Animal testing for chronic care cardiovascular devices | Observation of surgical procedures and chronic care maintenance in animal models using chronic care cardiovascular devices, such as heart valves and ventricular assist devices. |
Manufacturing of contact lenses and care products | All contact lenses and care products. |
Treatment of severe hearing loss | Surgical implantation of cochlear implants, electro-acoustic stimulation using hybrid cochlear implants, preservation of residual hearing, postoperative evaluation of residual hearing and implant performance. |
Auditory brainstem implants (ABIs) | Observation of ABI surgical procedures. |
Management of clinical trials for medical devices | Understanding clinical trial infrastructure, roles/responsibilities of your organization, and relationships with other organizations involved in the management and conduct of clinical trials; institutional review boards; clinical research organizations. |