Off-Label Use of Medical Devices

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Article Title:

Off-Label Use of Medical Devices

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Article Description:

How can a medical practitioner decide whether a medical device

that they want to use for one of their patients is legal and

approved by the Food and Drug Administration? When a patient

comes into a physician's office the patient is looking for the

best, most modern care they can get. And a physician certainly

wants the same thing.

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Distribution Date and Time: 2010-06-22 11:00:00

Written By: Norm Howe

Copyright: 2010

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Off-Label Use of Medical Devices

Copyright © 2010 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

How can a medical practitioner decide whether a medical device

that they want to use for one of their patients is legal and

approved by the Food and Drug Administration? When a patient

comes into a physician's office the patient is looking for the

best, most modern care they can get. And a physician certainly

wants the same thing.

This search for the best possible treatment presents a dilemma,

however. How does the physician know what can be legally

prescribed? When might the best treatment also be a treatment

that is still in the process of being developed? When might a

physician's search for the most advanced treatment cross over

into medical research, and where does FDA draw the line between

the two. The answer is clear in some cases, but not so clear in

others.

First let's define what we mean by medical research. Research in

the laboratory and on animals is usually called preclinical

research. When a medical device has been successful in

preclinical research the sponsor for a new medical device may

apply to FDA for a Investigational Device Exemption (IDE) which,

if approved, would allow for clinical research - research

involving human subjects - to prove that the device is safe and

effective on people.

When, and if, a device is approved by FDA, it is always approved

for a particular set of indications for use. FDA does not approve

a device for just any use.

If the physician is using a medical device strictly for the

practice of medicine, then FDA does not get involved. That is a

decision between the doctor and the patient. If, on the other

hand the physician's intent is to expand the indications of use

of the medical device, then he is engaging in clinical research

and must obtain an IDE approval beforehand.

Let's look at an example. Recently there has been research that

suggests that toenail fungus can be treated with laser. This is

an interesting development because toenail fungus cannot be

easily treated with either current internal or topical medicines.

The fungus is typically encapsulated under the toenail.

As of this writing there is no laser that has been cleared for

use in the treatment of toenail fungus. There are similar lasers,

however, that have been cleared for dental use.

If a physician were to use the laser that had been cleared for

dental use on an individual patient to treat a toenail fungus,

this is called off-label use. There is a fine line between legal

and illegal off-label use of medical devices. The difference lies

in the intent when the physician uses or prescribes the medical

device.

So how does FDA decide whether the physician is trying to expand

the indications of use? If the physician is focusing only on

what's best for an individual patient, then he/she is free to

pick the best treatment available. The physician should base his

decision on the medical literature and his professional judgment

of the risk versus benefit to that patient.

However, if the physician were to expand the practice to a number

of patients or to publish the data, then FDA would interpret the

work as performing clinical research and would require that the

physician submit an IDE to FDA. If the work is being supported or

advertised by the medical device company, that would be a clear

red light.

If the physician is unclear whether a proposed procedure would

fall into the category of clinical research he or she should

consult the Institutional Review Board of the hospital where the

work is being done.

For more information on this subject take VCI's e-learning

course <a href=http://www.vcillc.com/e-learning.html

target=_blank> Introduction to Medical Device Approval

Pathways</a> or call us at 734 274 4680.

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Norm Howe, Senior Partner at Validation and Compliance Institute,

consultants for the pharmaceutical and medical device industries.

He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.

He has held many management positions in FDA regulated industries,

most at BASF. http://www.vcillc.com