Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi,
​​We have a medical device class 1 product (510k) exempt. 

We are thinking about doing a sampling program (Free) with the product to get the products into new customers hands .  In doing so, we need to focus on the target market of the specific disease. 

If we giveaway samples and still meet the FDA regulation requirements for labeling and have a complaint process in place for comingling of these free samples vs. those that are truly reimbursement samples are there other requirements / liabilities we must meet?



Thanks​

As long as your establishment is registered, medical device is listed on the FURLS database (confirming device is Class I, 510(k) Exempt), complying with labelling requirements (801), complying with quality system requirements (820), and any other regulatory requirements.  There may be a little misconception that if free samples are given away then the requirements are not being met.  However, I worked with a couple companies that you used to give free product away to needing patients or needing charities because there were often patients that could not afford the product or healthcare.  As long as the regulatory requirements are being met, I think a company could give away as much product as they want !  Maybe update your customer ordering process on how free product/samples are handled is all.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 26-Jun-2018 09:53
From: Anonymous Member
Subject: Sampling program Free giveaways

This message was posted by a user wishing to remain anonymous

​Hi,
​​We have a medical device class 1 product (510k) exempt.

We are thinking about doing a sampling program (Free) with the product to get the products into new customers hands .  In doing so, we need to focus on the target market of the specific disease.

If we giveaway samples and still meet the FDA regulation requirements for labeling and have a complaint process in place for comingling of these free samples vs. those that are truly reimbursement samples are there other requirements / liabilities we must meet?



Thanks​

This message was posted by a user wishing to remain anonymous

​Good Morning Richard...

Thanks so much!! Updating ordering process for sample giveaways will need to be reviewed.
Have a wonderful day!!
Original Message:
Sent: 27-Jun-2018 05:42
From: Richard Vincins
Subject: Sampling program Free giveaways

As long as your establishment is registered, medical device is listed on the FURLS database (confirming device is Class I, 510(k) Exempt), complying with labelling requirements (801), complying with quality system requirements (820), and any other regulatory requirements.  There may be a little misconception that if free samples are given away then the requirements are not being met.  However, I worked with a couple companies that you used to give free product away to needing patients or needing charities because there were often patients that could not afford the product or healthcare.  As long as the regulatory requirements are being met, I think a company could give away as much product as they want !  Maybe update your customer ordering process on how free product/samples are handled is all.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 26-Jun-2018 09:53
From: Anonymous Member
Subject: Sampling program Free giveaways

This message was posted by a user wishing to remain anonymous

​Hi,
​​We have a medical device class 1 product (510k) exempt.

We are thinking about doing a sampling program (Free) with the product to get the products into new customers hands .  In doing so, we need to focus on the target market of the specific disease.

If we giveaway samples and still meet the FDA regulation requirements for labeling and have a complaint process in place for comingling of these free samples vs. those that are truly reimbursement samples are there other requirements / liabilities we must meet?



Thanks​

This message was posted by a user wishing to remain anonymous

You should look carefully at your targeting, the amount of samples you provide, and how you decide who receives them.  Giving away free goods always carries with it the risk of appearing to induce future purchasing or reward past purchasing, which can implicate the federal Anti-Kickback Statute and corresponding state laws.
Original Message:
Sent: 27-Jun-2018 09:51
From: Anonymous Member
Subject: Sampling program Free giveaways

This message was posted by a user wishing to remain anonymous

​Good Morning Richard...

Thanks so much!! Updating ordering process for sample giveaways will need to be reviewed.
Have a wonderful day!!
Original Message:
Sent: 27-Jun-2018 05:42
From: Richard Vincins
Subject: Sampling program Free giveaways

As long as your establishment is registered, medical device is listed on the FURLS database (confirming device is Class I, 510(k) Exempt), complying with labelling requirements (801), complying with quality system requirements (820), and any other regulatory requirements.  There may be a little misconception that if free samples are given away then the requirements are not being met.  However, I worked with a couple companies that you used to give free product away to needing patients or needing charities because there were often patients that could not afford the product or healthcare.  As long as the regulatory requirements are being met, I think a company could give away as much product as they want !  Maybe update your customer ordering process on how free product/samples are handled is all.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 26-Jun-2018 09:53
From: Anonymous Member
Subject: Sampling program Free giveaways

This message was posted by a user wishing to remain anonymous

​Hi,
​​We have a medical device class 1 product (510k) exempt.

We are thinking about doing a sampling program (Free) with the product to get the products into new customers hands .  In doing so, we need to focus on the target market of the specific disease.

If we giveaway samples and still meet the FDA regulation requirements for labeling and have a complaint process in place for comingling of these free samples vs. those that are truly reimbursement samples are there other requirements / liabilities we must meet?



Thanks​

Original Message------

As long as your establishment is registered, medical device is listed on the FURLS database (confirming device is Class I, 510(k) Exempt), complying with labelling requirements (801), complying with quality system requirements (820), and any other regulatory requirements.  There may be a little misconception that if free samples are given away then the requirements are not being met.  However, I worked with a couple companies that you used to give free product away to needing patients or needing charities because there were often patients that could not afford the product or healthcare.  As long as the regulatory requirements are being met, I think a company could give away as much product as they want !  Maybe update your customer ordering process on how free product/samples are handled is all.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Still required to maintain distribution records for the samples to meet 820.160 requirements; sometimes people get tripped up here by thinking the same rules don't apply to samples. If the sample distribution records are maintained separately from standard distribution records, the traceability / market withdrawal (recall) procedure should point to those sample distribution records.

------------------------------
Joshua Lust
Quality & Regulatory Affairs Manager
Grand Rapids MI
United States
------------------------------

Original Message:
Sent: 26-Jun-2018 09:53
From: Anonymous Member
Subject: Sampling program Free giveaways

This message was posted by a user wishing to remain anonymous

​Hi,
​​We have a medical device class 1 product (510k) exempt.

We are thinking about doing a sampling program (Free) with the product to get the products into new customers hands .  In doing so, we need to focus on the target market of the specific disease.

If we giveaway samples and still meet the FDA regulation requirements for labeling and have a complaint process in place for comingling of these free samples vs. those that are truly reimbursement samples are there other requirements / liabilities we must meet?



Thanks​

I agree that the anti-kickback issues are probably more sensitive than the FDA issues here, and below is a link to a 2018 OIG opinion on free samples from a DME manufacturer that explains the applicable rules.   If done properly (i.e., not as an inducement), a free sample or charitable give away program should be ok:    https://www.oig.hhs.gov/fraud/docs/advisoryopinions/2018/AdvOpn18-02.pdf

------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
------------------------------

Original Message:
Sent: 26-Jun-2018 09:53
From: Anonymous Member
Subject: Sampling program Free giveaways

This message was posted by a user wishing to remain anonymous

​Hi,
​​We have a medical device class 1 product (510k) exempt.

We are thinking about doing a sampling program (Free) with the product to get the products into new customers hands .  In doing so, we need to focus on the target market of the specific disease.

If we giveaway samples and still meet the FDA regulation requirements for labeling and have a complaint process in place for comingling of these free samples vs. those that are truly reimbursement samples are there other requirements / liabilities we must meet?



Thanks​