Regulatory Open Forum

When evaluating a Class 1 MDDS that allows for communication of medical data (heart rate, blood pressure, pulse oximetry rreadings, etc...) and non-radigraphic images from a camera, between locations, the FDA has recently stated that they will utilize enforcement discretion, and I am hearing mixed reports on whether the manufacturer will need to register their facility with FDA, list the device, and follow GMPs? If they register and list, are they required to follow full GMPs or is a risk based approach including records, complaints, design controls suffcient?

Another question, if the transmission is to a mobile device like an IPad  or IPhone, where a physician would review patient data and evaluate non-radiographic images from a camera looking at ear canal or skin lesions as stated above, what would be the regulatory controls over the ability to designate which devices it would be permissible to view the data and images on?  

Thanks

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Jeff Peacock
Vice President, Regulatory
Henry Schein
Melville NY
United States
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Jeff,

There was an FDA webinar on this topic that may be helpful for you.  It is here:  http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm433146.htm

The MDDS page is here:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/MedicalDeviceDataSystems/default.htm

The answers to your questions [directly from FDA] are likely there.  The Q&A of the webinar is probably the most informative part.  There are also some guidance documents that address this topic.  I have posted them as well as a couple of other documents that may be helpful.    I posted the draft versions of the guidances, too, as it is often helpful in understanding what is in the final version.  See them here:

https://graematter.egnyte.com/fl/5uDqexw9mD/Posted%20Items_

Enforcement discretion is exactly as it sounds.  FDA is not saying that the product is not a medical device, they are only saying that there will be no enforcement of requirements.  Sometimes it is everything - including registration and listing - and sometimes it is only some requirements.  In this case, note Dr.Shuren's statement in the Media Briefing document on that topic.  [In the posted files above.]

For your second question, the answer may hinge on whether or not the device provides "active patient monitoring."  There are some examples in the final MDDS guidance about medical image transfer devices.

Hope that helps.

Cheers,
Melissa

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Melissa Walker RAC
President & CTO
Graematter, Inc.
Saint Louis MO
United States
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Original Message:
Sent: 03-19-2015 12:07
From: Jeff Peacock
Subject: MDDS and Mobile Medical Apps

When evaluating a Class 1 MDDS that allows for communication of medical data (heart rate, blood pressure, pulse oximetry rreadings, etc...) and non-radigraphic images from a camera, between locations, the FDA has recently stated that they will utilize enforcement discretion, and I am hearing mixed reports on whether the manufacturer will need to register their facility with FDA, list the device, and follow GMPs? If they register and list, are they required to follow full GMPs or is a risk based approach including records, complaints, design controls suffcient?

Another question, if the transmission is to a mobile device like an IPad  or IPhone, where a physician would review patient data and evaluate non-radiographic images from a camera looking at ear canal or skin lesions as stated above, what would be the regulatory controls over the ability to designate which devices it would be permissible to view the data and images on?  

Thanks

-------------------------------------------
Jeff Peacock
Vice President, Regulatory
Henry Schein
Melville NY
United States
-------------------------------------------

There is a draft guidance document on low risk products. General Wellness: Policy for Low Risk Devices. It defines if your product is a little risk wellness product. If it is new registration for listing is required. If it is not, then there is FTA discretion still

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F. David Rothkopf
President
MEDIcept Inc.
Ashland MA
United States
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Original Message:
Sent: 3/19/2015 12:07:34 PM
From: jeff.peacock@henryschein.com
Subject: MDDS and Mobile Medical Apps

When evaluating a Class 1 MDDS that allows for communication of medical data (heart rate, blood pressure, pulse oximetry rreadings, etc...) and non-radigraphic images from a camera, between locations, the FDA has recently stated that they will utilize enforcement discretion, and I am hearing mixed reports on whether the manufacturer will need to register their facility with FDA, list the device, and follow GMPs? If they register and list, are they required to follow full GMPs or is a risk based approach including records, complaints, design controls suffcient? Another question, if the transmission is to a mobile device like an IPad  or IPhone, where a physician would review patient data and evaluate non-radiographic images from a camera looking at ear canal or skin lesions as stated above, what would be the regulatory controls over the ability to designate which devices it would be permissible to view the data and images on?   Thanks ------------------------------------------- Jeff Peacock Vice President, Regulatory Henry Schein Melville NY United States -------------------------------------------