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 C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips
Appendix C: Premarket Notification: A Key Element of US Medical Device Regulation--Larry Kessler and Philip J. Phillips
Pages 75-112
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From page 75... ...
Today's 510(k) program is the result of a conscious effort to provide reasonable regulation in light of the agency's inability to develop mandatory performance standards for class II medical devices and inadequate FDA resources to withstand any appreciable shift in the numbers of new 75
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From page 76... ...
Plagued with vague concepts such as substantial equivalence, intended use and predicate devices, the program is particularly vulnerable to intermittent inconsistencies in how each concept is interpreted and applied in agency decision-making, as well as misunderstanding by stakeholders that monitor FDA activity. Coupled with the fact that all medical devices are subject to eventual failure, and failure rates are among the most challenging data to understand, demand for regulatory reform is not unexpected.
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From page 77... ...
, including medical devices related to licensed blood and cellular products, while a small, but growing number of devices are combined with drugs and biologics (referred to as combination products) that are regulated by the FDA center with responsibility over the product's primary mode of action.
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From page 78... ...
It is on this basis that class III devices are subject to the highest levels of FDA's regulation, including general controls and any relevant performance standards and special controls, and a "device-by-device" demonstration of safety and effectiveness through a regulatory process known as premarket approval (PMA)
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From page 79... ...
The manufacturer should apply the following principles in the priority order listed: 3A diminishing number of preamendment class III devices remain subject to 510(k) review.
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From page 80... ...
• Facilitate international trade of medical devices. The GHTF is organized around study groups that have written over 30 guidance documents that, when adopted by GHTF partners, will bridge the different regulatory systems.
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The company could elect to submit a STED. CDRH has encouraged medical device manufacturers to participate in the STED pilot program.
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, FDA made a significant effort to group all medical devices in existence at the time, commonly referred to as preamendment devices, into generic device types with each generic type of device being "a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness."6 Each generic device type was then further categorized by medical specialty and referred to the appropriate classification panel(s) comprising independent experts, principally within the medical specialty.
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From page 83... ...
In essence, the medical device industry came to quickly realize that there was a greater likelihood of their new devices' being cleared if they were compared to legally marketed devices with similar intended uses and technological characteristics. While comparison to pre-1976 devices is not precluded, such comparisons in today's 510(k)
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From page 84... ...
Just as knowledge and experience influenced the initial classifications, information derived from experience with class III devices has paved the way for occasional reclassification actions. With the passage of time and an accumulation of experience, FDA has gained confidence that some class III device types can be safe and effective and that lesser FDA regulation will continue to ensure their safety and effectiveness.
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From page 85... ...
The statutory provision, referred to as de novo classification, allows companies that receive NSE decisions to request that their devices be regulated in class I or II and allows FDA an opportunity to avoid unnecessary class III regulation. To date, there have been 55 de novo classifications that have been granted creating the same number of new generic device types.
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From page 86... ...
Further, in addition to the general controls of the Act, the Office of In Vitro Diagnostic Device Evaluation and Safety developed the following special controls: 1. "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System," which includes recommenda tions for performance validation and labeling; 2.
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From page 87... ...
a preamendment class III device would eventually be subject to PMA and that all NSE devices were automatically placed in class III, immediately subject to PMA, 510(k) was merely the means of ensuring that new devices are subject to appropriate FDA regulatory requirements.
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From page 88... ...
program is not largely fulfilling Congress's intent.10 THE CONCEPT OF SubSTANTIAL EquIvALENCE Between 1976 and 1986, substantial equivalence was not defined. In fact, the only guidance bearing directly on the issue of SE can be found in the Report of the Committee on Interstate and Foreign Commerce on the Medical Device Amendments of 1976 (Senate report)
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of the act, a medical device is SE to a predicate device if it has the same intended use as the predicate device; and (1) it has the same technological characteristics as the predicate device or (2)
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From page 90... ...
In an October 6, 2005, draft guidance document titled Functional Indications for Implantable Cardioverter Defibrillators, FDA defined functional indications for use as "an indication statement for a medical device that describes what the device does and does not specify an indicated patient population." As an example, many surgical sutures have indications-for-use statements that only specify that the device is to be used for the approximation of soft tissue, with no reference to specific tissues, anatomical sites or surgical procedures. While a device's indications-for-use statement represents a large part of a device's intended use for determining SE, intended use in this context also encompasses: who is intended to use the device, where it is intended to be used and under what conditions the device is to be used.
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From page 91... ...
program, the concept of intended use as applied to determining SE becomes clearer. In essence, intended use is a regulatory concept that is the first consideration when determining the boundaries of a generic type of device and is most often constructed to encompass the widest breadth of use where the regulatory controls for the generic device type continue to provide reasonable assurance of safety and effectiveness.
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From page 92... ...
Of course, to fully address this perceived premarket weakness, extensive premarket human testing for all new materials or compounds would be needed, thereby taxing FDA's capacity to review products. Historically, scientific knowledge pertaining to legally marketed class I and II devices has transcended generic device types leading to the appearance of comparisons to multiple devices in a single 510(k)
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From page 93... ...
FDA classified the TephaFLEX® Absorbable Surgical Suture in class II (21 CFR 878.4494) and established special controls in the form of a guidance document titled Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate)
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From page 94... ...
While the objective of providing a reasonable assurance of safety and effectiveness is the same regardless of the pathway to market, the agency's means of ensuring it is quite different when contrasting class I and II devices with class III devices that are subject to PMA. The safety and effectiveness of class I and II devices is ensured through conformance with the regulatory controls that are associated with a generic type of device and its regulatory class.
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In essence, establishing special controls was done when "convenient" for the agency. How does FDA address safety and effectiveness issues relating to class II devices without having mandatory performance standards or special controls?
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For class III devices, conformance with GMPs is assessed on a preapproval basis. In other words, before a new class III device is sold in the United States, FDA has visited the manufacturing facility and determined that the facility is operating in conformance with GMP requirements.
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From page 97... ...
While FDA requests for data can be challenged, clearances are not forthcoming unless the requested data are provided or the data are determined not to be necessary for clearance. Changes and Modifications to Legally Marketed Devices Medical devices have a very short life cycle when one considers the number of changes that a typical device undergoes during the course of a year.
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From page 98... ...
(ii) -- "effectiveness" equivalence" Threshold for FDA market authorization "Reasonable assurance of safety and "Substantial equivalence" effectiveness" Regulatory Difficulties Premarket Approval (PMA)
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Standard NA Postapproval studies Frequently required as COA NA Control over promotion and advertising Possible as COA No materials Authority to withdraw approval Yes No Authority to temporarily suspend approval Yes No Authority to rescind final decision No No Review Times Premarket Approval (PMA) Premarket Notification (510(k)
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cGAO Report. Medical Devices -- FDA Should Take Steps to Ensure That High-Risk Device Types are Approved through the Most Stringent Premarket Review Process.
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From page 101... ...
with FDA. The details of this aspect of US device regulation go beyond the scope of this paper, however, the regulatory issues created when regulating rapidly changing products must be a consideration when exploring alternative regulatory schemes.
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In the world of class III devices, every manufacturer must generate its own data on its own device and cannot rely on any data that are contained in competitors' approved PMAs. Ability to Grant Exemptions When 510(k)
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From page 103... ...
s based on concern regarding off-label use of the device. In amending the law with FDAMA 97, Congress recognized the importance of allowing new medical devices that are SE to go to market even if a potential for off-label use is evident.
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From page 104... ...
These practices suggest that obtaining FDA clearance for biliary use was a ruse to avoid the rigors of PMA approval for class III stents intended for use in the vasculature. Regardless of the manufacturers' intent, the challenge relating to this situation affects the PMA path to market as well as 510(k)
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From page 105... ...
(ii) states that any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness.
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From page 106... ...
What is needed is a means of encouraging the development of improved technology that is not dependent on premarket review to implement. The development of performance standards or agency guidance that encourages product improvement over time with verification of company progress during FDA facility inspections is a viable model.
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From page 107... ...
If the new scientific information raises issues that would question prior decision-making, then FDA should resolve them without disadvantaging select companies and through maintaining a "level playing field." If FDA has concerns with a group of devices, the agency has the means to rectify the situation without disadvantaging companies seeking market authorization for new devices. Promulgation of special controls, including mandatory performance standards, issuance of public health advisories, guidance documents and agency use of the "bully pulpit," is an effective means of prompting change.
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Are criteria for applying these standards transparent and grounded in good science and do they lead to good health care? All medical device standards are developed to help ensure safety and effectiveness leading to good public health.
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From page 109... ...
In an FDA guidance document, the agency acknowledges this industry approach to differentiating devices in order to capture market share from competitors.17 Drivers of Change: Cost Containment and the Practice of Medicine The quest to control spiraling health-care costs is a major factor that influences device design and use today. When combined with the ever changing demands imposed by the practice of medicine, significant forces are created that drive the medical device industry to innovate.
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From page 110... ...
For class III devices, regulation can be reasonably straightforward, but for simple devices, the addition of drugs and biologics can create complex scientific issues. FDA's Office of Combination Products (OCP)
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From page 111... ...
The current approach to development of guidance is needlessly burdensome on all parties and displays the bureaucracy failing in a simple, but effective means to promote and protect the public health. CONCLuSION Ensuring that all medical devices are safe and effective entails a complex system of requirements, with Section 510(k)
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From page 112... ...
http://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/GuidanceDocuments/uc m085994.htm (accessed July 21, 2010)
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