I recently read with interest a comment by a regulatory colleague about how a pre-filled syringe (PFS) should continue to be regulated as a drug with a primary package rather than a combination product for the principal reason that the product has been on the market for many years and has been proven safe and effective.

Well…. if a syringe without content is regulated as a device, then why would prefilling the device with a drug change its regulatory requirements for registration/approval? Does prefilling the device supersede the product’s device categorisation even though the syringe maintains the same intended use?

GMDN: General-purpose syringe/needle

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

To what standard do we regulate changes to this “primary package” for the PFS? Same as for a hard shell capsule?

At what point does the product change categorisation
from a drug with a primary package
to this device?

I understand, regulatory affairs personnel occupying various roles in pharmaceutical companies without a medical device portfolio may find the compliance requirements related to both FDA’s 21 CFR 3.2(e)(1) and MDR Article 117 onerous and inconvenient. However, these requirements that one may consider an inconvenience are in fact necessary to apply a globally recognised and consistent regulatory approach to support the continued validation of the safety and efficacy of this combined drug/device product.

Please feel free to contact me to discuss your drug/device combination product RIM requirements. KimYoung@instem.com

K Young