The FDA is seeking public comment on its custom medical device exemption criteria following some changes implemented through the FDA Safety & Innovation Act, which was signed into law earlier this year.
The proposed rules include 4 main tenets for fitting the definition of a custom medical device as well as limits on annual production and use.
The federal watchdog agency is seeking "information on and examples of appropriate uses" of the custom medical device exemption system, especially input from patients, manufacturers, dentists and physicians on circumstances in which they have or would like to use custom devices.
The FDA’s custom device criteria, according to a federal notice, include exemption for a device which fits the following definitions:
- Is “created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing)”;
- must not be “generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution”;
- must be for the purpose of treating a “unique pathology or physiological condition that no other device is domestically available to treat”; and
- must be manufactured for the “special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of the physician or dentist (or other specially qualified person so designated)” or by an individual patient named in such order.
The new rule also requires that a custom device only treat "a sufficiently rare condition such that conducting clinical investigations on such device would be impractical," and production must be limited to no more than 5 such devices per year, according to a FDA notice in the Federal Register.
Medical device makers have experienced some snafus over the custom medical device exemption system.
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics in January announced it would discontinue its custom orthopedics division after in response to an FDA warning following an inspection of the Warsaw, Ind.-based company’s facilities.
Mid-January the FDA’s Centers for Devices & Radiological Health released a letter warning DePuy that certain custom devices and components sold by the company need new PMA or 510(k) applications.
The watchdog agency detailed more than a dozen devices or device components it said lacked proper FDA clearance or which were modified in ways that merit a new 510(k) application.
Just days after the warning was unsealed, DePuy announced that it would permanently stop production of all custom devices, not just the dozen or so listed in the warning letter, DePuy spokeswoman Jessica Masuga confirmed with MassDevice.com at the time.
Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.
You can hear her story and more when you register for DeviceTalks Boston, October 8-10.
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