Guidance Documents (Medical Devices and Radiation ... | 合法醫療器材資訊網

2019年10月11日—HomepagefortheCDRHGuidanceDocumentsection.

Search for FDA Guidance Documents[1] What is guidance?

Guidance documents are prepared for the FDA’s staff, regulated industry, and the public to describe the FDA’s interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:

the design, production, labeling, promotion, manufacturing, and testing of regulated products the processing, content, and evaluation or approval of submissions inspection and enforcement policies

Guidance documents do not establish any rights for any person and is not binding on FDA or the public. An alternative approach may be used if it satisfies the requirements of the applicable statue and regulations.

Additional Information Contact FDA

1 (800) 638-2041 ...

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About FDA Guidance Documents. Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person ... Read More

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2021年2月10日 — Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not ... Read More

Guidance Documents (Medical Devices and Radiation ... | 合法醫療器材資訊網

2019年10月11日 — Home page for the CDRH Guidance Document section. Read More

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2021年5月12日 — Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics including ... Read More

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Product | 合法醫療器材資訊網

FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available. In addition to the provided information, sponsors ... Read More

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