Food | FDA

Infant Formula Information & Resources ; Updates on Highly Pathogenic Avian Influenza (HPAI) ; On the Road with the Deputy Commissioner for Human Foods

510(k) Clearances | FDA - U.S. Food and Drug Administration

General Information ; Medical Device Safety and the 510(k) Clearance Process ; Total Product Life Cycle for Medical Devices ; Premarket Notification 510(k) ; Safety and Performance Based Pathway

Search for FDA Guidance Documents | FDA - U.S. Food and Drug Administration

Browse Guidance Documents By Topic · About FDA Guidance Documents · Commenting on Guidance Documents · Report on Good Guidance Practices

eSTAR Program | FDA - U.S. Food and Drug Administration

Update: August 22, 2024 · The FDA issued final guidance on using the Electronic Submission Template (eSTAR) for submitting De Novo requests for medical devices. This guidance establishes an implementation date of October 1, 2025, for required use of eSTAR for De Novo submissions. eSTAR is now available for voluntary use for 513(g) requests for information to CBER.

미 FDA, 혁신적인 기기 프로그램(Breakthrough Devices Program) 가이드라인 초안 발표

프로그램(FDA drug expedited programs)과 유사한 것으로, 기기 인증에 필요한 데이터 일부를 시판 후 추적과정을 통해 수집함으로써 조기에 시장 출시 가능 ** 대체 치료법이 없는 의료기기에 대한...

FDA: User Fees Explained | FDA - U.S. Food and Drug Administration

What are user fees? ; The FDA collects fees from companies that produce certain products, such as drugs and medical devices, and from some other entities, such as certain accreditation and certification bodies. These fees are called “user fees.” Federal law authorizes the FDA to collect user fees to supplement the annual funding that Congress provides for the agency. User fees help the FDA fulfill its mission of protecting the public health and also facilitate timely availability of innovative FDA-regulated products without compromising the ...

FDA-TRACK: Agency-wide Program Performance | FDA - U.S. Food and Drug Administration

FDA-TRACK is FDA’s agency-wide performance management system.

Sterilization for Medical Devices | FDA - U.S. Food and Drug Administration

Ethylene Oxide ; Why Is Ethylene Oxide Used to Sterilize Medical Devices? ; What Devices Are Sterilized with Ethylene Oxide? ; How Does the FDA Help Ensure that Medical Devices Sterilized with Ethylene Oxide Are Safe? ; EPA's Role in Ethylene Oxide Sterilization

MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA

Prescription and over-the-counter medicines ; Biologics such as blood components, blood/plasma derivatives and gene therapies. ; Medical devices such as hearing aids, breast pumps, and pacemakers. ; Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray.

510(k) Submission Programs | FDA - U.S. Food and Drug Administration

On this page: A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional, Special, and Abbreviated. The Traditional Program is the original submission type as provided in 21 CFR 807. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements. These Programs were previously described in The New 510(k) Paradi ...