FDA Guidance Documents
This FDA website allows access to links to a wide variety of FDA Guidance Documents and allows the user to search for specific Guidance Documents.
Newly Added FDA Guidance Documents
This FDA website includes links to new guidance Documents are retained in the website for a period of three months.
FDA Warning Letters
This FDA website provides the ability to browse warning letters issued by the FDA. Warning letters are segregated by year. You can also use the advance searching capabilities to search the site for a specific warning letter or specific types of warning letters by company, issuing office, subject, etc.
21 CFR Database Search
This FDA website provides the ability to search the Code of Federal Regulation Title 21 both by the reference Part number and by using a text search.
510(k) Premarket Notifications
This FDA website provides the ability to search all the501(k)s submitted by Type, panel, product code, 501K number, applicant name, device name, decision date or by using a text search.
Office of Manufacturing and Product Quality
This FDA website includes links to Office of Manufacturing and Product Quality Guidance Documents, Guidance Manuals, and selected publications and presentations. It also contains links to Current Good Manufacturing Practices (cGMPs) information.
Guidance for Industry, FDA Reviewers & Compliance on Off-The-Shelf Software Use in Medical Devices
This FDA document was issues September 9, 1999 and supersedes the document, Guidance on Off-the-Shelf Software Use in Medical Devices, June 4, 1997.
Medical Device Registration and Listing
This FDA website provides information concerning who must register a medical device, how to register, list and pay the fee to register a medical device.
Medical Device Quality Systems Manual
FDA document – A Small Entity Compliance Guide First Edition (Supersedes the Medical Device Good Manufacturing Practices [GMP] Manual)
Vaccines, Blood & Biologics Guidance Documents
This FDA website includes links to Blood and Blood Component Guidance Documents. Links to New 2011 Guidance Documents are included below:
Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma – Draft July 2011
Donors of Blood and Blood Components: Notification of Donor Deferral – Small Entity Compliance Guide – June 2011
Computer Crossmatch Guidance – April 2011
Infectious Disease Tests
This FDA link provides access to several links with list of approved test for a variety of infectious diseases and ones approved for donor screening.
FDA Acronyms and Abbreviations
This FDA website allows the user to perform searches of FDA acronyms and abbreviations
This FDA website allows users to search for cleared devices
510(k) Premarket Notification Search
This FDA website allows the user to search 510(k) notifications by date, applicant name, device name, type, 510(k) number, etc.
Small Business Guide to FDA – Updated 2011
This FDA website provides a link to a downloadable (pdf) version of the Small Business Guide to the FDA. This guide provides information specifically presented to help small businesses use the Federal Register, comment on proposed regulations, obtain agency documents and regulations, petition the FDA, communicate with the FDA, handle an inspection, and find the appropriate contacts within FDA for the assistance they need.