A recent article on Medical News Today’s website entitled “FDA Takes ‘First Step’ Toward Greater Regulatory Certainty Around Nanotechnology” reviews FDA’s June 9th release of a draft guidance that provides regulated industries with greater certainty about the use of nanotechnology.
What implications does FDA’s guidance have on the medical technology field? Let’s first briefly review what exactly constitutes nanotechnology. To define the term simply, nanotechnology is the study of manipulating matter on the atomic and molecular scale. Over the past decade, nanotechnology has been dubbed by the scientific world as “The Next Big Thing.” Furthermore, you have undoubtedly seen evidence of this in the consumer world with the introduction of products such as the iPod “Nano.” While the iPod Nano is not “nano-sized,” it incorporates nanotechnology in the way it functions. In fact, a number of products from cell phones and laptops to teddy bears and golf clubs utilize nanotechnology in their development. More importantly for human health, nanotechnology has been used in the formation of a number of drugs and devices used to treat a number of ailments, perform surgeries, and may even have future applications for rebuilding damaged parts of the human body.
FDA’s new draft guidance is an attempt to better define the characteristics and behavior of engineered nanomaterials for products which are subject to pre-market review. Hopefully, FDA’s draft guidance and future guidances will guide quality research that will prevent future exposure of harmful nanomaterials to humans. However, those of us who have been working with these fascinating technologies for years recognize that this is only a first step, and is long overdue. FDA is accepting comments on the draft guidance for 60 days after its June 9th release. To see the guidance document, click here.
To see the original article from Medical News Today, click here.