Unravelling the red tape in medical device compliance

Carolyn Algar presented an interesting seminar on medical device compliance, which based on the attendance and number of questions asked, is certainly a hot topic within the medical device development community. She provided an excellent overview of the international regulatory arena and compared the requirements for obtaining FDA registration as well as CE and/or ISO certification.

South Africa is currently drafting standards for medical device compliance which are closely aligned with the CE standards that are used in Europe. Medical devices are categorised into three levels according to their risk (class one being lowest risk) with different levels of testing and supporting clinical data being required for each level. The CE mark does not cover chemicals, pharmaceuticals or food.

Carolyn highlighted the importance of ensuring that labelling requirements are followed carefully especially for FDA registration. One important aspect of a medical device often overlooked during the registration process is the software component - this also needs to comply with specific standards and undergo testing. She stressed the importance of implementing design control early on in the development process as it is difficult to retrofit this after the fact and it can significantly delay the registration process, especially if a quality system has also not been put in place. Employing consultants to navigate through the different regulatory requirements can save significant amounts of time as it is difficult to determine specific requirements in certain instances and learn from scratch.

For entirely novel medical devices FDA premarket notification (510k) takes a staggering 411 days between submission and the deadline by which the FDA needs to respond and the cost is around $100,000! For devices that are similar to those already on the market (i.e. a 'predicate' device is being marketed), the process is much faster (90 days) and less expensive ($3,000).

Download Carloyn's presentation here.

Biography

Carolyn Algar is a UCT graduate, with an Honours Degree in Cell Biology and Postgraduate Diploma in Enterprise Management, Carolyn Algar has a wealth of practical experience in the medical device registration / certification area having worked for PointCare Technologies in Massachusetts (USA) in QA/QC after working for incubator Acorn Technologies in Cape Town as a Senior Business Analyst. Carolyn is currently providing consulting services to clients such as PointCare and Frost & Sullivan (France).

She will unfortunately be returning to the USA in April 2008.