Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
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Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr.
Appendix D: Impact of the Regulatory Framework on Medical Device Development and Innovation--David W. Feigal, Jr.
Pages 113-128
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From page 113... ...
The US Food and Drug Administration (FDA) Critical Path initiative focused on the science of development: better toxicology, biomarkers, improved clinical trials, and personalized medicine, but that initiative, like others including the re-engineering initiatives of the 1990s and legislative changes that accompanied device user fees, did not examine the regulatory structure of the approval process itself and how the regulatory structure determines the choices in the science of development.
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From page 114... ...
Parallel to the scientific and public health life cycle is the in vitro diagnostic product life cycle (see Figure D-2)
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From page 115... ...
Once introduced into the market and in widespread use it isn't long before the development life cycle repeats as the next generation tests are developed and improve the diagnostic test. The scientific and product life cycles are interconnected and involve coordinated efforts by clinicians, academic research groups from many scientific disciplines, local, national and international public health organizations, and the regulatory oversight of research by institutional review boards (IRBs)
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From page 116... ...
at FDA has promoted the total product life cycle as a framework for medical device regulation. The origins of the US medical device laws were embedded in the US drug laws, and before the 1976 Device Amendments to the Food, Drug, and Cosmetic Act, some medical devices were approved with new drug applications (NDAs)
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. A product designer or regulatory reviewer will have more insight into design challenges when considered along with failure mode analyses done after the recall of a similar product or in light of the product specific problems identified on compliance inspections.
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11 THE FDA 510(k) ClEARANCE PROCESS FIGuRE D-3 Total product life cycle.
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From page 119... ...
The lowest risk devices are required to meet general controls, register their facilities and list their devices but in large part are only regulated by FDA "for cause" when problems are identified. The highest risk products, the class III PMA products have development paths that are very similar to new drug development, as described briefly above.
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From page 120... ...
The statutory default which assumes novel products, that is, products without a predicate, are class III products hampers innovation. DEvICE CLASSIFICATION AND INNOvATION By page volume, the largest part of the US FDA device regulations are devoted to describing approximately one thousand different medical device classifications.
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To illustrate, a diagnostic device for cancer prognosis in someone already known to have breast cancer is a class II risk device. The same diagnostic, if solely relied on to make a specific treatment decision for breast cancer, would be a class III risk device.
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process. Just as FDA guidances promote innovation, standards provide a predictable regulatory framework.
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From page 123... ...
The quality of the device needs attention throughout the product life cycle. Innovations in medical devices are not just big fixes and big improvements.
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From page 124... ...
Designing medical gas delivery devices so that a vacuum hose can't be hooked up where the oxygen hose was supposed to be is a simple example of human engineering.3 A product with technology that has human factors innovations is particularly important for high risk devices and medical products designed for home use. 3Which has not entirely prevented users from welding a custom adapter to thwart that protection, an example of reverse human engineering.
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From page 125... ...
More examples of the impact of regulation and innovation are found in the gaps between FDA and other consumer protection regulations. Laboratory developed tests4 fall in such a gap between FDA's regulation of in vitro diagnostic devices manufactures, the CLIA regulation of clinical laboratories, and the state medical boards' regulation of the practice of laboratory medicine.
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From page 126... ...
The potential for HDEs to foster innovation has not been reached because of the regulatory burdens of the program. Refine the methodology for collecting clinical performance data across the product life cycle and across product generations.
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CDRH should have the resources to make classification reviews an on-going and dynamic process, complete a guidance document for every product classification, create an oversight process for a mandatory ISO 13485 certification by third party inspectors, develop a gap-closing process with CLIA for oversight of lab based tests that is streamlined and risk based, and continually seek proposals on how to maintain a vibrant and innovative medical device development community.
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From page 128... ...
. http://www.fda.gov/MedicalDevices/Device RegulationandGuidance/GuidanceDocuments/ucm080235.htm (accessed June 1, 2010)
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