FDA's Strategies on the Regulation of Medical Products: How do they look like?

FDA's Center for Devices and Radiological Health (CDRH) published its strategic objectives regarding medical devices for 2013 in a document entitled "2013 Strategic Priorities". The document is composed of 12 pages and describes 6 priorities for 2013. These priorities are:

1. Ensuring that patients in the USA have access to high-quality, safe, and effective medical devices of public importance first in the world.

2. Assuring that the USA is the world's leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.

3. Securing that the US market surveillance system quickly identifies poorly performing devices and accurately takes the relevant measures.

4. Guaranteeing that medical devices are legally marketed in the USA and remain safe, effective and of high-quality.

5. Making sure that, consumers, patients, etc., have access to understandable information about medical devices and use this information for their health care decisions.

6. Modernisation of the working conditions.

These general priorities are precisely described in each respective subchapter. To achieve the first objective (Ensuring that patients in the USA have access to high-quality, safe, and effective medical devices of public importance first in the world) the FDA plans for example to strengthen the "pre-market-review" programme and to modernize clinical trials. A date has been set for the achievement of these sub-points. By 31 March 2013, the CDRH wants to have improved the management of pre-market review content and processes by incorporating commercial technologies and standardized information management practices.
Moreover, the document begins with the presentation of the "Mission" (protection and promotion of the public health) and the "Vision" (which covers the first five priorities named above). The "Shared Values" are also defined. They include the FDA staff but also the explanation of transparency with the general public.

Conclusion: Those who want to have a quick overview of CDRH's strategic objectives for 2013 can find easily and quickly all detailed information in the compact "2013 Strategic Priorities" document.

For further information please see the complete document "2013 Strategic Priorities".

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