FDA Draft Guidance on Syringe Connection Problems Reemphasizes Need for Early Agency/Sponsor Dialogue on Combo Products; Postapproval Change Guide Issued

A new draft guidance from FDA on glass syringe connection problems, which have been associated with serious adverse events and quality issues over the past few years, reemphasizes the need for early dialogue between combination product sponsors and the agency to avoid potential design and development pitfalls.

A key focus of FDA’s draft – released in early April with a 90-day comment period – is that conformance with the ISO 11040-4 technical standard has not been enough to avoid the connection problems that have been surfacing.

Early meetings with the agency, it advises, will help make sure that the specific design and development challenges for the sponsor’s product are understood and addressed.

The guidance identifies supplemental tests that should be performed and recommends possible design modifications to ensure that glass syringes are properly connected to drug delivery devices such as needles for injection, IV lines, and luer locks.  It also provides recommendations for conducting human factors (HF) studies to assure that the product works properly in the hands of the practitioner or user.

At a CASSS CMC Strategy Forum on biological/device combinations held in Bethesda, Maryland in July, CDRH Office of Device Evaluation Regulatory Director Lana Shiu discussed the adverse events that called the connection problems to the agency’s attention (see box below).

[CLICK HERE for the complete story.and includes a discussion by CDRH reviewing official Jacqueline Ryan on potential obstacles that combination products may encounter in application review and how to avoid them.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]