Search Databases | 合法醫療器材資訊網

2021年2月1日—AnimalDrugs@FDAisanonlinedatabaseofFDA-approvedanimaldrugs....Disclosureofthecompliancestatusoffirmshelpstoprovidethe ...

Medical Device Compliance and Enforcement Portal[1]

FDA conducts inspections of medical device manufacturers to ensure they comply with the regulations about device safety and effectiveness. When a medical device violates FDA law, FDA can take action to enforce compliance and ensure public health. Two main tools are Warning Letters and Recalls. In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily).

Inspections Database[2]

The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firms compliance with regulations and the Food, Drug and Cosmetic Act. The Agency is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public...

How do I find out if a drug is approved? Is there a Web site I ... | 合法醫療器材資訊網

Approvals of FDA | 合法醫療器材資訊網

2018年3月29日 — Approval information by product type. ... or diagnosing disease (such as thermometers, artificial hearts, and home pregnancy test kits). Read More

Search Databases | 合法醫療器材資訊網

2021年2月1日 — Animal Drugs @ FDA is an online database of FDA-approved animal drugs. ... Disclosure of the compliance status of firms helps to provide the ... Read More

Drug Approvals and Databases | 合法醫療器材資訊網

2020年6月18日 — Additional topics include: approved REMS, drug shortages, and the Orange ... Inactive Ingredient Search for Approved Drug Products Search Read More

Search Registration and Listing | 合法醫療器材資訊網

2017年12月23日 — Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment ... Read More

Device Approvals | 合法醫療器材資訊網

2018年3月26日 — Search the PMA Database. Regulation also provides for the submission of a humanitarian device exemption (HDE) application. Read More

Drugs@FDA | 合法醫療器材資訊網

Drugs@FDA: FDA-Approved Drugs · Search by Drug Name, Active Ingredient, or Application Number* · Browse by Drug Name. Read More

Search for FDA-Approved Drugs - Drugs | 合法醫療器材資訊網

Recent New and Generic Drug Approvals - Drugs | 合法醫療器材資訊網

For comprehensive approval reports, please use the monthly All Approvals report on Drugs@FDA. 7 Day Report; 14 Day Report. July 14, 2021. Drug Name and Read More

510(k) Premarket Notification | 合法醫療器材資訊網

... that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. Read More

相關資訊整理