Search for FDA Guidance Documents
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, …
Guidances | FDA - U.S. Food and Drug Administration
2025年1月17日 · Guidance documents describe FDA’s interpretation of or policy on a regulatory issue (21 CFR 10.115 (b)). In general, FDA’s guidance documents do not establish legally …
U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by …
Scientific Publications by FDA Staff - Food and Drug Administration
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510(k) Premarket Notification - Food and Drug Administration
2025年3月24日 · A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally …
美国FDA认证自愿性共识标准：符合性声明的使用
2020年9月7日 · 美国食品和药物管理局（FDA认证）是医疗器械领域的监管机构，允许制造商在准备和评估医疗器械上市前申报时使用国家和国际自愿性共识标准。 为了帮助医疗器械制造商 …
Recognized Consensus Standards: Medical Devices - Food and Drug …
2024年12月23日 · This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity for medical devices. After FDA …
FDA believes the recommendations in this guidance document for a Traditional or Abbreviated 510(k) will conserve FDA and industry resources and facilitate timely review. This guidance …
Historical Documents - open.fda.gov
Historical Documents endpoint allows you to search FDA past press releases on topics of your interest
Guidance Documents (Medical Devices and Radiation-Emitting Products) | FDA
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.
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