The Food and Drug Administration is an agency within the United States Department of Health and Human Services and consists of a number of centers and offices, one of the United States federal executive departments..

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health.

The International Genetically Engineered Machine (iGEM) competition is a worldwide Synthetic Biology competition aimed at undergraduate university students.

Student teams are given a kit of biological parts at the beginning of the summer from the Registry of Standard Biological Parts. Working at their own schools over the summer, they use these parts and new parts of their own design to build biological systems and operate them in living cells. Randy Rettberg, an engineer who has worked for companies including Apple, Sun and BBN, is the director of the iGEM competition.

One of the aims of the competition is to attempt to build simple biological systems from standard, interchangeable parts and operate them in living cells.

The iGEM competition facilitates this by providing a library of standardized parts (called BioBrick standard biological parts) to students, and asking them to design and build genetic machines with them. Student teams can also submit their own BioBricks. Successful projects produce cells that exhibit new and unusual properties by engineering sets of multiple genes together with mechanisms to regulate their expression.

Information about BioBrick standard biological parts, and a toolkit to make and manipulate them, is provided by the Registry of Standard Biological Parts, or simply, the Registry. This is a core resource for the iGEM program, and one that has been evolving rapidly to meet the needs of the program.

The international organisation responsible for developing and maintaining worldwide standards for manufacturing, environmental management systems, computers, data communications, and many other fields

A series of international standards for quality assurance in business practices, ratified by the ISO beginning in 1987. Certification of ISO 9000 compliance is important for selling many types of goods and services including data-communications equipment and services.

Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose.

ISO 9001 is by far the world’s most established quality framework, currently being used by over ¾ million organizations in 161 countries, and sets the standard not only for quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

ISO 9000 series of standards

ISO 9001 is one of a series of quality management system standards. It can help bring out the best in your organization by enabling you to understand your processes for delivering your products/services to your customers. The ISO 9001 series of standards consist of:

• ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
• ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
• ISO 9004 – Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.

Who is it relevant to?

ISO 9001 is suitable for any organization looking to improve the way it is operated and managed, regardless of size or sector. However, the best returns on investment come from those companies that are prepared to implement it throughout their organization rather than at particular sites, departments or divisions.

In addition, ISO 9001 is designed to be compatible with other management systems standards and specifications, such as OHSAS 18001 Occupational Health and Safety and ISO 14001 Environment. They can be integrated seamlessly through Integrated Management. They share many principles so choosing an integrated management system can offer excellent value for money.

ISO 13485, published in 2003, and now fully recognized in many countries, is based on the ISO 9001 process model approach.  These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.

Certification to ISO 13485 takes place when an accredited third party, such as BSI, visits an organization, assesses the quality management system and, if satisfactory, issues a certificate confirming that the organization’s quality management system meets the requirements of the standard.

Your BSI quality management systems certificate is objective, accredited, recognized evidence of your company’s commitment to quality systems and helps you demonstrate this to customers and regulators. BSI is accredited by the United Kingdom Accreditation Service (UKAS) and the Standards Council of Canada (SCC). ISO 13485 is becoming widely accepted as the international standard to address medical device requirements around the world.

The standard can be used by manufacturers to demonstrate applicable regulatory requirements, and by other organizations whose related services support medical device manufacturers.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.