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On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.

In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).

Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?
According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.

In the world of injection molding, experience, expertise, and a passion for sharing knowledge can transform careers and shape the future of the industry. Ron Barr, a seasoned Principal Process Engineer at West, is a testament to this philosophy. With a remarkable journey that began back in 1991 when he joined the workforce at the age of 19, Ron's story is an inspiration to aspiring professionals in the field.

With employees’ students across the U.S. receiving $5,000 each year over four years, the Foundation fosters a culture of support for education and family at West.

In September 2023, Dr. Bettine Boltres, West’s contact for scientific affairs and technical solutions for glass, shared with us the most frequently asked questions that she encounters on glass-related topics. We are pleased to share Part 2 of the series where Dr. Boltres will share the remainder of the 10 most common questions she gets asked concerning glass vials.
You can read Part 1 of the series here.