a custom device in medical devices is made to match the anatomical feature of a patient, this could be like skull implant (notice that I am answering the question from orthopedic points of view). All implants (hip, knee,...etc) could be custom made but they require longer time to fabricate and they cost more. On the other hand they save more time in surgery and save more material in removal of bone. I hope this gives you some insight into the answer

Thank you Gaffar Gailani.

What is the prevailing regulatory mechanisms while using custom devices? Does an IRB need to review the use of such a device?

You welcome,

This is a good question. In USA I would say it will be complicated, but I am not sure of the process. I am sure it is practiced in USA in some types of cancer at least. However, I read some research papers by authors from Columbia in latin america (do not remember other countries) for real life case studies they did where even a surgery has been performed, and there was no mention of IRB, though they used it in a surgery. I attended a talk for Dr. Kuthe from Visvesvaraya IT in India who was visiting the USA last year, and he it seems like they have done it for different types of patients. So rules will depend on the country. I am trying to explore this subject further also.

back to the process you can also see this link http://biomedical.materialise.com/cases

In the US, per SEC. 520. 21 U.S.C. 360 of the Food, Drug and Cosmetic Act - a device that

" (A) 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);

(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515;

(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;

(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;

(E)(i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or

(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated);

(F) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and

(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. "

[See guidance https://www.fda.gov/media/89897/download ]

In the EU, per MDR -

"Any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional

qualifications which gives, under that person's responsibility, specific design

characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs."