Regulatory Open Forum

In theory, FDA requires the Sponsor of the device to assert whether Rx or OTC (or both) are appropriate. This is based on the particular indications for use authored by the Sponsor, which may be different for every device.  For example, in its 510(k)-format guidance, FDA states, "...We believe that in order for FDA to adequately review your submission you should identify whether the device is intended for prescription use and/or over-the-counter use."  [emphasis added by ComplianceAcuity]

Similarly, in the same guidance, FDA instructs Sponsors that, "...A device may be intended for both prescription and over-the-counter use. If so, the answer to both of these questions [i.e., answers the Sponsor provides in its cover letter to characterize the device design and use] is yes." [emphasis added by ComplianceAcuity].

Likewise, the foregoing comments are echoed in FDA's 510(k) Indications for Use form to be completed by the Sponsor, where the Sponsor must select the "type of use" as either Rx or Prescription, or both, as applicable.

Because the final official decision is made on a case-by-case basis for each device, it is difficult for there to be a set list of the devices that always or never require Rx or OTC.  For example, one might expect the designation to be recorded with the corresponding device classification regulations and product codes, yet no such designation is made therein by the agency.

I personally haven't ever seen such a list from the FDA since my entry into the profession in the mid-nineties. On the other hand, there are of course many devices for which the law of common sense would seem to demand prescription use.  And make no mistake about it, FDA will push back on a Sponsor's "type of use" assertion prior to clearance/approval if needed to protect the public health.

Nonetheless, it will be interesting to hear others' thoughts on this.  Looking forward to the Forum's additional input.

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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com

Original Message:
Sent: 13-Sep-2017 17:31
From: Patty Beja
Subject: Rx vs OTC Medical Device Designation

​​Team!

Aside from the Rx/OTC designations on the 510K summary letters where can one see which product codes are innately Rx? I am trying to wrap my head around Rx designations of items whose corresponding FDA product codes do not require 510K.
Is there a reference site or list for this informaiton? I feel like I am flying by the seat of my pants on this. Some class 1 items seem to beg for Rx designation but I need to show concrete proof.

Thanks!

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Patty Beja
Regulatory Affairs Associate
Drive Devillbiss Healthcare
Port Washington NY
United States
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