Medical Device Development

Kaplan, Aaron V.; Baim, Donald S.; Smith, Jordan; Feigal, David; Simons, Michael; Jefferys, David; Fogarty, Thomas J.; Kuntz, Richard E.; Leon, Martin B.

doi:10.1161/01.cir.0000134695.65733.64

Cited by 154 publications

(74 citation statements)

References 3 publications

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“…6 Devices are classified into a 3-tiered system (Class I-lowest risk; Class II-intermediate risk; Class IIIhighest risk). 8 …”

Section: United Statesmentioning

confidence: 99%

“…Some examples of products in class I category are handheld surgical instruments, tongue depressors and crutches etc. [8][9][10] Class II devices Class II devices are those higher-risk devices for which only general controls are inadequate to establish safety and effectiveness, and for which there are sufficient data to substantiate special controls. Because these devices pose a greater risk of harm compared to class I devices and hence they are bound by added regulation of special controls, which may be confirmed by the FDA.…”

Section: Class I Devicesmentioning

confidence: 99%

“…Generally, this class of device includes hightechnology products such as cardiac monitors, tampons, infusion pumps, surgical drapes and oxygen masks. 8,9 Class III devices The class III devices are those which are either life-sustaining/supporting or of considerable importance in averting impairment of human health. Examples of class III devices are pacemakers, heart valves, coronary stents etc.…”

Section: Class I Devicesmentioning

confidence: 99%

“…Therefore, most class III devices need premarket approval (PMA) from FDA before they can be launched. 8 …”

Section: Class I Devicesmentioning

confidence: 99%

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Medical Device Regulations: A Current Perspective

Gupta¹

2015

J YOUNG PHARM

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There has been an upsurge in the number, diversity, and intricacy of medical devices in last two decades. Regulation of these devices has also advan ced due to the requirement for a steady regulatory perspective. Various regulations of medical devices across major economies of the world were reviewed and then other pertinent issues of medical device regulations were discussed. The regulatory guidelines for medical devices in various countries which include United States, Europe, Japan, India, Brazil Japan, Australia etc. were reviewed. The need for harmonization of the device regulations and other regulatory issues were also assessed. Since the early 1980s, the regulatory paradigm for medical devices has changed exceptionally. Currently there are many countries which have enforced medical device regulations. Now with the availability of different regula tions of the countries or region on medical devices, there is a need to harmonize regulations in order to curtail regulatory hurdles and expedite access to high quality, safe and efficacious medical devices. Most coun tries are trying to harmonize the regulatory guidelines for medical devices through their participation in Global Harmonization Task Force (GHTF).Harmonized regulation of medical device will lead to the availability of quality product.

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“…6 Devices are classified into a 3-tiered system (Class I-lowest risk; Class II-intermediate risk; Class IIIhighest risk). 8 …”

Section: United Statesmentioning

confidence: 99%

Section: Class I Devicesmentioning

confidence: 99%

Section: Class I Devicesmentioning

confidence: 99%

“…Therefore, most class III devices need premarket approval (PMA) from FDA before they can be launched. 8 …”

Section: Class I Devicesmentioning

confidence: 99%

See 2 more Smart Citations

Medical Device Regulations: A Current Perspective

Gupta¹

2015

J YOUNG PHARM

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show abstract

“…[125][126][127] Clinical trials to establish superiority, or at least noninferiority, to currently approved treatments, such as fusion, require regulatory approval and study-site IRB review. 128 An understanding of the regulatory process is critical to planning the efficient introduction of important new technologies. However, this arduous process is expensive, and raising sufficient funds to execute a well-conceived clinical trial typically relies on solid intellectual property protection, and corporate or venture capital support.…”

Section: Cost Effectiveness Analyses and Outcomesmentioning

confidence: 99%