Regulatory Open Forum

It's not something I do; however, I am curious about it,

What type of submission would be required to add an alcohol swab for disinfecting the skin to a carton containing an autoinjector (CBE-30, PAS etc.)? If your product labeling mentions alcohol swab (not supplied) and now you want to add it in your carton and mention it in your IFU, depending how your labeling was approved under (NDA, BLA, or PMA or 510 (k)), following changes to such applications to update your labeling is the best route to take. For example, if it's a prefilled autoinjector with drugs approved under an NDA, looks like you will need a supplement (a CBE) to update your labeling, the IFU portion.

Would the alcohol swab need to be approved via a 510k? Alcohol swab falls into device classification type "enforcement discretion" - "Devices for which FDA applies enforcement discretion and therefore pre-market review is not necessary, require additional instructions before they can be listed in FURLS/DRLM." If you are a manufacture of alcohol swab, you should contact FDA to obtain information to list such a device.

It's not something I do; however, I am curious about it,

What type of submission would be required to add an alcohol swab for disinfecting the skin to a carton containing an autoinjector (CBE-30, PAS etc.)? If your product labeling mentions alcohol swab (not supplied) and now you want to add it in your carton and mention it in your IFU, depending how your labeling was approved under (NDA, BLA, or PMA or 510 (k)), following changes to such applications to update your labeling is the best route to take. For example, if it's a prefilled autoinjector with drugs approved under an NDA, looks like you will need a supplement (a CBE) to update your labeling, the IFU portion.

Would the alcohol swab need to be approved via a 510k? Alcohol swab falls into device classification type "enforcement discretion" - "Devices for which FDA applies enforcement discretion and therefore pre-market review is not necessary, require additional instructions before they can be listed in FURLS/DRLM." If you are a manufacture of alcohol swab, you should contact FDA to obtain information to list such a device.

It's not something I do; however, I am curious about it,

What type of submission would be required to add an alcohol swab for disinfecting the skin to a carton containing an autoinjector (CBE-30, PAS etc.)? If your product labeling mentions alcohol swab (not supplied) and now you want to add it in your carton and mention it in your IFU, depending how your labeling was approved under (NDA, BLA, or PMA or 510 (k)), following changes to such applications to update your labeling is the best route to take. For example, if it's a prefilled autoinjector with drugs approved under an NDA, looks like you will need a supplement (a CBE) to update your labeling, the IFU portion.

Would the alcohol swab need to be approved via a 510k? Alcohol swab falls into device classification type "enforcement discretion" - "Devices for which FDA applies enforcement discretion and therefore pre-market review is not necessary, require additional instructions before they can be listed in FURLS/DRLM." If you are a manufacture of alcohol swab, you should contact FDA to obtain information to list such a device.

It's not something I do; however, I am curious about it,

What type of submission would be required to add an alcohol swab for disinfecting the skin to a carton containing an autoinjector (CBE-30, PAS etc.)? If your product labeling mentions alcohol swab (not supplied) and now you want to add it in your carton and mention it in your IFU, depending how your labeling was approved under (NDA, BLA, or PMA or 510 (k)), following changes to such applications to update your labeling is the best route to take. For example, if it's a prefilled autoinjector with drugs approved under an NDA, looks like you will need a supplement (a CBE) to update your labeling, the IFU portion.

Would the alcohol swab need to be approved via a 510k? Alcohol swab falls into device classification type "enforcement discretion" - "Devices for which FDA applies enforcement discretion and therefore pre-market review is not necessary, require additional instructions before they can be listed in FURLS/DRLM." If you are a manufacture of alcohol swab, you should contact FDA to obtain information to list such a device.

To address the original poster's first question, adding such a product to the package of the autoinjector (presumed to itself be a combination product with a drug or biologic primary mode of action) would definitely be a prior approval supplement as this would necessitate a change in the labeling (USPI). It may also require a change in the instructions for use (IFU) depending on how such a swab is already presented (or not).

Regarding classification of such a swab as a drug or device - this is a separate and more complicated issue. FDA has traditionally regulated swabs to disinfect the surface of the human body as a drug (antiseptic) and was subject to a recent (2017) final rule on the subject (although FDA stayed a decision on acceptable ingredients, i.e. alcohol). Additionally, antiseptics used in first aid already have an OTC drug monograph (21 C.F.R. 333). Here's an example of such a swab (there are many other brands available, though); note that it caries an NDC number (a search through the NDC directory will likely yield other results).

Meanwhile, swabs used to disinfect medical devices would also be classified as devices, see product code LKB (that others have mentioned, is unclassified and is subject to FDA enforcement discretion).

Based on the original poster's proposed usage, the swab should be a drug (OTC) and carry an NDC.

Now, one can certainly argue about the classification of such a swab as a drug or device based on the definitions in 21 U.S.C. 321 (and some have indeed done that, with some examples in the case law that I didn't look up for this reply), but that's a separate matter. If there are strong thoughts on that topic, the FDA's docket is still open (until Oct 8, 2021) for feedback on drug vs. device classification issues stemming from the Genus Medical appellate ruling earlier this year which specifically concerns imaging agents, but FDA explicitly requested "Stakeholders are invited to submit comments regarding categories of products currently regulated as drugs that may be required to transition to device status under Genus. Comments are also welcome regarding statutory provisions other than the drug and device definitions that may indicate Congressional intention regarding the appropriate regulatory pathway (i.e., drug or device) for certain types of products." So, good timing if folks are interested in that topic!

Finally, regarding if one should include swabs with such a product to begin with - Lee is correct that it definitely complicates matters (quality issues with the swabs or not) and that should be considered. Additionally, note that (in the US, at least) many pharmacies (including specialty/mail order pharmacies that typically supply autoinjectors for chronic use) provide ancillary supplies by default. So, it would be worth checking with one's commercial organization to determine the true need before going through those efforts.