To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a draft guidance for industry titled Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.
The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product.
Depending on the system and its applications, these elements may fall under various regulatory provisions such as 21 CFR 3.2(e) or 510(k). The document discusses the scientific and technical considerations that may be relevant when developing these systems, regardless of the regulatory provisions that apply.
The draft guidance discusses design features as well as general use, conditions of use (e.g., personal use, use by healthcare professional, and disposable or reusable products), and injector materials used to construct or manufacture each device. The document provides a list of the various performance testing standards (ISO and ASTM) that are recommended and discusses separate tests such as biocompatibility, dose accuracy, shelf-life stability, and expiration dating. Sterilization and sterility testing is also discussed in detail.
A copy of the draft guidance can be downloaded for the purposes of providing a comment.
See related PharmTech articles:
S. Sutton, EPT, Prefilled Syringes Growing More Popular
N. Motlekar, Online Exclusive, Designing and Delivering Therapeutic Proteins
B. Harrison and M. Rios, May 2007, Big Shot: Developments in Prefilled Syringes
D. McCormick, Oct. 2006, Developing First Disposable Injector for a Biopharmaceutical