FDA Communication on Use of Jet Injectors with Influenza Vaccines
"The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Biojects Needle-Free Injection Devices, the Biojector® 2000 and the Bioject® ZetaJet™, are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs," said Ralph Makar, Biojects President and CEO. "We are looking into the matter to better understand the situation and the FDAs concerns. A number of Biojects Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner."
As stated in the FDA 510(k) clearance letters for our needle-free devices, the two devices below are cleared for the following indications for use:
Biojector® Needle-Free Injection Management System, Biojector® 2000
Indications For Use: The Biojector® 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector® B2000 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector® 2000 may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
Bioject® ZetaJet™ Needle-Free Injection Therapy System
Indications For Use: The Bioject® ZetaJet™ is indicated for delivery subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Bioject® ZetaJet™ may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Bioject® ZetaJet™ may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.
Bioject Medical Technologies Inc., based in Portland, Oregon, USA, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and work by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. Bioject is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies, as well as research, global health and government organizations.
For more information about Bioject, visit www.bioject.com.