FDA guidance to nanotechnology products

Nanotechnology is an emerging area which can create many new materials for medical devices, medicine, electronics and energy industries. On the other hand, more and more concerns about nanotechnology are raised about the toxicity and environmental impact of nanomaterials. 

Today, FDA issues three final guidances and one draft guidance to support the responsible development of nanotechnology products (the link).

In guidances, FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. It aims to help industry when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products. FDA advises industry to consult with FDA early in the development process to facilitate a mutual understanding of the specific scientific and regulatory issues for their nanotechnology products.

In "Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology", FDA identifies two Points to Consider that should be used to evaluate whether FDA-regulated products involve the application of nanotechnology.

1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm);
2. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).

Japan Visting

This week we have a chance to visit the factory of a well-known Japan chemical & materials company. A ond-day visiting in Tokyo and some photos nearby the hotel:

Suica

Different Needs that Guide the Design and Development of Medical Devices

The customers of medical devices are involved patient, doctor, nurse and purchasing agent who has different preference. The book Combination Products: Regulatory Challenges and Successful Product Development" (page 39) gives a summary of typical voices of customers for using combination products, which is a good reference for medical devices as well:

• Patient: Needs to be safe, should be covered by insurance, result in minimum pain with no side effects, etc. 

• Doctor: Needs to be easy to use/intuitive, have less morbidity/mortality and excellent and proven clinical benefits. Easy to place during procedure, excellent support from sales rep, overwhelming clinical superiority.

• Nurse: Easy to use, store, unwrap, dispose, clean and sterilize; minimal nurse supervision of the patient. clear instructions with plenty of pictures, ergonomic and intuitive.

• Purchasing agent: Cost-effective, reimbursable, excellent product-related service, clear codes that can easily be entered in system.

新修订的中国《医疗器械监督管理条例》Revised Version of “The Regulations for the Supervision and Administration of Medical Devices”

昨天中国发布了修订的《医疗器械监督管理条例》。条例分为8章80条（相比2000年的条例为4章48条）。

和2000年4月施行的条例（以下称旧条例）比较，一些个人感觉重要的修改总结如下： 

1. 总则

新条例第一条去掉了“为了加强对医疗器械的监督管理”。可能是为了突出“为了保证医疗器械的安全、有效”的医疗器械监督管理原则和目的。

新条例将医疗器械的定义放在了附则部分。将旧条例中医疗器械所指的“单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品”改为“直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品”。明确了间接用于人体的体外诊断（in vitro diagnostics）试剂和医疗器械等作为医疗器械的一部分。医疗器械使用目的中相应加入了“通过对来自人体的样本进行检查，为医疗或者诊断目的提供信息”。

新条例增加了国务院和县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作的内容。明确了有关部门如工商、卫生、质监、海关、公安等参与到医疗器械的生产、经营和使用的监督管理工作。

Imagemagick

Install Imagemagick, a powerful command line image tool, with Homebrew in my iMac.
1. install XQuartz first, download file from http://xquartz.macosforge.org
2. brew install imagemagick --with-x11
3. convert logo: logo.gif; display logo.gif

Pass FDA 's Tests

FDA websites, specially Center for Devices and Radiological Health (CDRH) is certain to the first study source for medical device industry and research. After study carefully of 21 CFR part medical device, cosmetics and drug, CDRH learn materials, I have passed serveral important tests.