<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Excluded from this document are drug delivery methods which:</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.</span></p>
Registration number (WIID)
82503
Scope
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.</span></p>
<p class="MsoBodyText" style="mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">Excluded from this document are drug delivery methods which:</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);</span></p>
<p class="ListContinue1" style="line-height: 11.5pt; tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">—<span style="mso-tab-count: 1;"> </span>infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.</span></p>
