Hello Anoosha,
To follow on with what good advice Jonathan provided is determining the Primary Mode of Action for the drug and device. If the nasal spray device is only intended to administer the drug product, then as a "combination product" would be considered just a component as Jonathan stated. But is the nasal spray device has other purposes or configured in a different manner than as explained, i.e. reusable, refillable, cartridge, etc., then may need to go back to the Mode of Action for proper determination on regulatory status.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 27-Feb-2024 06:48
From: Jonathan Amaya-Hodges
Subject: Regulatory Pathway for Nasal spray
Annosha,
It sounds like you are developing a new platform/system that is intended for pharmaceutical manufacturer use and will only be sold in a pre-filled configuration. In this case it would be a component of the finished combination product, noting that the device constituent (spray function) and the primary container are part of said component.
In this case, no independent device registration is required, however relevant combination product regulations (e.g. 21 CFR §4) must be followed in collaboration with your pharma partner(s). Due to this, I would recommend planning ahead in terms of meeting key requirements and current regulatory expectations, which likely means seeking expert advice (in case that does not already exist within your organization). Feel free to reach out by DM if you'd like to discuss further.
Otherwise, best of luck!
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Jonathan Amaya-Hodges
Director, Technical Services
Suttons Creek, Inc.
United States
jamaya-hodges@suttonscreek.com
Original Message:
Sent: 26-Feb-2024 01:28
From: Anoosha Bhat
Subject: Regulatory Pathway for Nasal spray
Hello Everyone,
We are in the process of developing a Nasal Spray Device used for Administering the medication into Nasal Cavities. Drug will be filled into it by other Pharma company and will be marketed in USA by them.
As per US FDA, this device falls under Class-1 510(k) exempt. In this case, what is the registration pathway we have to choose and what would be requirements that has to be fulfilled by the device and what comes under our scope as a device manufacturer.
Please share your valuable inputs.
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Anoosha Bhat
Bengaluru
India
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