Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Please excuse me if this topic has been raised previously and I am overlooking it. I have a fairly strong understanding of how/where service animals, emotional animals and therapy animals are permitted in business settings, but what I am not certain of is how the allowances fit into a medical device manufacturing setting. Is the business owner allowed to permit certain areas where a service animal (as defined by the ADA) is allowed (e.g. production, lab or warehouse)? Does anybody know of a specific FDA regulation that addresses this type of situation, perhaps as it relates to GMP? TIA

I haven't seen anything from FDA specifically addressing the question. Common sense will say most places where it's ok for humans to shed hairs and skin particles it's also ok for dogs, and where it's not ok for humans it also not ok for dogs. For example if you're using a cleanroom for assembling devices that need a limited bioburden prior to sterilization, you can't let a dog in (unless it's able to don a bunny suit). Also considering the animal's safety, you can't let it unprotected into areas where eye protection, hearing protection, or chemical safety protection is needed.

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Anne LeBlanc
United States
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Original Message:
Sent: 04-Mar-2022 16:19
From: Anonymous Member
Subject: Service Animals in Medical Device Manufacturing Facility

This message was posted by a user wishing to remain anonymous

Please excuse me if this topic has been raised previously and I am overlooking it. I have a fairly strong understanding of how/where service animals, emotional animals and therapy animals are permitted in business settings, but what I am not certain of is how the allowances fit into a medical device manufacturing setting. Is the business owner allowed to permit certain areas where a service animal (as defined by the ADA) is allowed (e.g. production, lab or warehouse)? Does anybody know of a specific FDA regulation that addresses this type of situation, perhaps as it relates to GMP? TIA

I raised a guide dog puppy many years ago when I worked at a medical device manufacturing facility.   I collaborated with the EHS team to determine where it would be safe for the dog and for the equipment to allow the dog to enter the facility.   I worked in the office but had meetings that would require me to cross the manufacturing floor.   There were portions of the facility that I needed to avoid when I brought the dog in.   We worked out the accommodations to be appropriate.   Each situation will be unique so I suggest putting a plan in place that meets the needs of those involved.   Emotional support pets are not covered under the same legal protections as a service animal.

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Tracey Fox RAC
Director, Medical Device Regulatory Affairs
Pewaukee WI
United States
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Original Message:
Sent: 04-Mar-2022 16:19
From: Anonymous Member
Subject: Service Animals in Medical Device Manufacturing Facility

This message was posted by a user wishing to remain anonymous

Please excuse me if this topic has been raised previously and I am overlooking it. I have a fairly strong understanding of how/where service animals, emotional animals and therapy animals are permitted in business settings, but what I am not certain of is how the allowances fit into a medical device manufacturing setting. Is the business owner allowed to permit certain areas where a service animal (as defined by the ADA) is allowed (e.g. production, lab or warehouse)? Does anybody know of a specific FDA regulation that addresses this type of situation, perhaps as it relates to GMP? TIA