You need to be familar with the following documents:

You can access these documents over Wizfolio here.

FDA Guidance Documents

 Guidance documents

FDA put out a number of guidance documents on various topics.  For medical device please see this link.  For your design project one of the first thing you want to do is to look at this website to see if there is a guidance document for your intended design.  If not, try and find a guidance document that is similar, for example if you are designing an ankle replacement prosthesis, if there is no guidance document on ankle prosthesis then you may want to try and look for one on knee or hip replacement.

Design Control Guidance

Attached to bottom of this webpage is a .pdf describing how best to implement Design Controls. This is a short document aimed at helping design industries better themselves by highlighting strategies that companies can undergo to ensure that their design processes are more efficient, and relevant while identifying and correcting problems much earlier resulting in a greater customer satisfaction upon delivery of product.

This is applicable to you directly as a BN3101 student as the goal of this course is to improve upon your design skills through experience, practice, and in this document's case, introduction of new strategies.

References for Bioethics


Mandatory Reading

Belmont Report (US) 1979

Declaration of Helsinki

Bioethics Advisory Committee Report (Singapore) - Section VI - Researcher and Section VII - Institutions

Optional Reading

Beecher : Ethics and clinical Research, NEJM 1966, 274: 1354-60.

What makes clinical research ethical? Emmanuel EJ, Wendler D, Grady C, JAMA 2000 Vol 283 No 20: 2710-2711.

Monitoring clinical research: report of one hopsital’s experience by Jane McCusker, Zita Kruszewski, Belaine Lacey, Benjamin Schiff, CMAJ, May 1, 2001; 164(9).

Quality of informed consent in cancer clinical trials: a cross sectional survey by Steven Joffe, E Francis Cook, Paul D Clearly, Jeffrey W Clark, Jane C Weeks, The Lancet, Vol 358, November 24, 2001.

Interpretation of the Bolam Test in the standard of medical care: Impact of the Gunapathy case and beyond by Catherine Tay Swee Kian, Tolley’s Profesisonal Negligence, Vol 19, No 2, 2003, pages 384-394.

Is there a scientific rationale for placebos? NEJM 11 August 1994, vol 331, no 6, 394.

Casey Chan MD,
Jul 30, 2012, 10:47 PM