Pre-Market Exhibition of Medical Devices
Aware of the importance of such premarket exhibition, FDA permits the display of investigational and unapproved medical devices. But the agency has its concerns and therefore limits such display. FDA’s some concerns are listed below:
- A sponsor of an investigational device may be a biased source of information with an interest in making claims for the device beyond what the clinical trial data support. Allowing sponsors to put their own spin on research results, the agency believes, could undermine the impartial scientific evaluation of investigational devices.
- It also could allow sponsors to create false or misleading impressions about a device among potential users, impressions that the agency fears could be difficult to dispel if the device is later approved for more limited use.
- To the display of marketed devices that are under investigation for a new use or that have a 510(k) pending for such a use. Because FDA does not regulate the practice of medicine, users can engage in off-label uses without interference from the agency. FDA fears that displaying marketed devices for new uses may encourage such off-label uses before the agency has evaluated their safety and efficacy.
DEVICES WITH 510(k) SUBMISSIONS PENDING:
- A device with a pending 510(k) may be displayed and advertised if the manufacturer does not solicit or accept any purchase orders. In addition, all claims made about the device must adhere to the intended use for which the 510(k) notification is pending.
- Devices with pending 510(k)s be displayed with the label “Pending 510(k), not available for sale within the United States.”
- A better solution would be to require manufacturers to provide upon request written certification of intent to submit 510(k)s for displayed devices.
FDA issued a guideline clarifying that a sponsor may publicize the availability of an investigational device to recruit clinical investigators for proposed or ongoing clinical trials. guideline indicates that a sponsor should:
- Announce the availability of the device only in medical and scientific publications or at medical or scientific conferences whose readership or audiences are composed primarily of experts qualified by scientific training and experience to investigate the safety and effectiveness of devices.
- State in clear terms that the purpose is only to obtain investigators and not to make the device generally available
- Limit the information presented in any notice of availability to the following: the name and address of the sponsor, how to apply to be an investigator, and how to obtain the device for investigational use. The notice should further list the investigator’s responsibilities during the course of the investigation: namely, to await Institutional Review Board (IRB) and FDA approval before allowing any subject to participate, to obtain informed consent from subjects, to permit the device to be used only with subjects under the investigator’s supervision, to report adverse reactions, to keep accurate records, and, more generally, to conduct the investigation in accordance with the signed agreement with the sponsor, the investigational plan, FDA’s regulations, and whatever conditions of approval are imposed by the reviewing IRB or FDA.
- Use direct mailing for the sole purpose of soliciting qualified experts to conduct investigations.
- Include the following statement displayed prominently and in print at least as large as the print in the notice: “Caution¬ Investigational Device, Limited by Federal (or United States) Law to Investigational Use.”
- Make only objective statements concerning the physical nature of the device.
- Ensure that no claims are made which state or imply, directly or indirectly, that the device is reliable, durable, dependable, safe, or effective for the purposes under investigation or that the device is in any way superior to any other device.
- Not present comparative descriptions of the device with other devices but may include reasonably-sized drawings or photographs of the device.
- Not include information regarding pricing data but may include information stating where such data may be obtained. A sponsor or investigator should not offer volume discounts for an investigational device. FDA would regard such discounts as the promotion of an investigational device.
- FDA may explicitly permit the display of investigational devices with an approved IDE if labeled “Work in progress.” It also may allow the display of devices with a pending PMA application if labeled “Pending PMA, not available for sale within the United States
- The safest course for the sponsor, therefore, would be to follow the rules for displaying investigational devices rather than those for devices with a pending 510(k).
PREVIOUSLY APPROVED OR CLEARED DEVICES UNDER INVESTIGATION FOR NEW USES
If a device has received 510(k) clearance or premarket approval, it may be displayed and promoted only for its cleared or approved uses. There can be no promotional display of investigational or unapproved new uses.
DEVICE WITH FOREIGN APPROVAL ONLY
The agency has stated that such a device may be brought into the country if certain conditions are met which are as follows:
- The device must be accompanied by entry forms that disclose its unapproved status.
- The manufacturer must indicate that the device is being imported solely for “testing or evaluation” and include a statement that remaining product will be destroyed or exported.
- When the device is actually on display in the United States, it must be labeled “Not available for sale in the United States,” and no sales orders may be taken.
Summary of current FDA requirements for the display of investigational or unapproved devices:
- If a device is on the market, it should be displayed and promoted only for cleared or approved uses.
- Investigational devices should not be promoted or otherwise represented as safe or effective.
- If a device has a 510(k) pending, it should be displayed only for the intended uses covered by the submission.
- Manufacturers who observe these three tenets almost certainly will avoid running afoul of the agency when showing an investigational or unapproved device whether the display takes place in a downtown convention center or in cyberspace.
|Regulatory Status||Type of Acceptable Labeling and Promotion while on Display|
|510(k) submission pending (no IDE and device not available for sale in the United States)||Promote only for intended uses covered by pending 510(k) submission.|
|Approved IDE||Follow 1985 guideline and add label, “Caution – Investigational Device, Limited by Federal Law to Investigational Use.”|
|PMA application pending||Follow 1985 guideline and add label, “Caution – Investigational Device, Limited by Federal Law to Investigational Use.”|
|510(k) pending (IDE)||Follow 1985 guideline and add label, “Caution – Investigational Device, Limited by Federal Law to Investigational Use.”|
|Already available for sale in the United States but a new use is under investigation or FDA review||Promote only for previously cleared or approved uses unless the device would require modification by the manufacturer to perform the new use.|
|Foreign approval only (no IDE, 510(k), or PMA application pending)||Label device as “Not Available for Sale in the United States.” If the device is manufactured abroad, may import with certification that it is for testing and evaluation and will be reexported or destroyed afterward.|
|Foreign approval for a use different from use approved in United States||Promote only for U.S. approved use.|
I If you would like to discuss any of concerns above email us at email@example.com and reference FDA update – Pre: market concerns