This is the second part of an extract from our White Paper. For more, read our free whitepaper: Three-Dimensional Printing and the Food and Drug Administration


Steps Taken by the Food and Drug Administration

Because of these concerns and the increased prevalence of these devices in health care, the Food and Drug Administration has been investigating how to properly evaluate these 3D priners.

In August 2013, they updated the system that they use to process Investigational Device Exemptions and emergency use authorizations to accommodate such devices. These changes will allow health care practitioners increased access to these devices. They also sponsored a workshop in October 2014 to discuss technical challenges and solutions regarding devices made with three-dimensional printers.

Some of the propositions submitted by stakeholders included methods for validation and quality control of these devices.

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Three-dimensional printing is revolutionizing the way medical conditions are treated. These printers are able to create customized medical devices and other medical products for patients.

Moreover, this new market is open to any manufacturer, not just medical device companies. Therefore, manufacturers should understand the trends associated with this growing use of technology.

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December 12, 2014

A Brief Overview of ISO9001

ISO 9001 is one of the most well-known quality system standards.

Like all official standards, it periodically goes through a review process in which it is updated. The next revision will be issued later in 2015.

The document is now in the draft international standard stage, which is the fifth stage in a six-stage process. In January, the final draft international standard will be released for voting. The final version will be available in September 2015.

Although becoming certified and maintaining certification in ISO 9001 requires an organization to invest time and money, the advantages include improved business performance and increased sales, as well as compliance with various countries quality systems requirements.

As such, organizations should understand the reasons for the revision, the changes in the revised document, and the impact on re-certification.

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To monitor public health more effectively, the United States government has issued regulations requiring organizations that manufacture and distribute devices to register with the Food and Drug Administration.

As such, any corporation or individual looking to market a device in the United States should understand the regulations and processes involved in registration.

Requirements for Registration

Per the Food and Drug Administration Amendments Act of 2007, Title 21 Code of Federal Regulations Part 807, and authorizations of the United States Congress, domestic owners of corporations that manufacture and distribute devices, people who operate a business that manufactures devices, foreign owners who import devices, and designers are required to register their facility with and pay a fee to the Food and Drug Administration once per year.

Small businesses must pay the same fees as larger businesses.

Foreign manufacturers must also select a United States Agent to act on their behalf.

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