In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management.  Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.”  The guidance covers the general quality risk management process but discusses the roles and responsibilities...Read More

What is a Real-Time PMA Supplement? Section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act defines a Real-Time PMA Supplement as: “a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software,...Read More

The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today.  The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...Read More

Email: Industry.Biologics@fda.hhs.gov Phone: 240-402-8020 or 1-800-835-4709 After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays) FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240 What The MATTB Does CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide...Read More

FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.Read More

For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  Read More

The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures ActRead More

/docs/FDADrug-25591_Data-Integrity.pdfRead More

http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htmRead More

/Docs/FDA-BECS510kworkshopTranscript110909.pdfRead More

/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdfRead More

/docs/FDA-DraftProcessValidationGiuidance111808.pdfRead More

https://www.softwarecpr.com/docs/CBERbecsvalidationguidanceDraft1007.pdfRead More

/docs/CBERaccessoriesIVD0506.pdfRead More

/Docs/BloodBank-FDA-CBER-CPG-0906.pdfRead More

FDA’s Center for Biologics Evaluation and Research issued the following: “Compliance Program Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002” This guide mentions software and computer systems in one paragraph which is provided below: “Computers: The performance of computer software must be validated (if customized) or verified (if used “off-the-shelf”) for...Read More

/docs/TransfusionSafteyManagementSystems-FDApresentation09-Mar-06.pdfRead More

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdfRead More

/Docs/ElectronicLabeling-mdufmasummary112304.pdfRead More

/Docs/PlasmaInspections7342002bld-SCPRcomputerhighlights.pdfRead More

The following question was asked during the “Ask the FDA” session (326-QE) on 10/25/04 at the AABB Annual Meeting held in Baltimore, MD as reported by SoftwareCPR Partner Molly Ray: When blood establishment computer software manufacturers distribute their device (software) for beta testing, they are required to label the software in accordance with the IDE...Read More

/docs/barcodelabelrule0304.pdfRead More

Guidance for Industry and FDA Staff Providing Regulatory Submissions in Electronic Format — General Considerations.  Document dated Oct 22, 2003. This guidance focuses on use of pdf files. It provides many specific requests in construction of the pdf for suitability for electronic submissions. These include resolutions, pagination, preference for digital instead of scanned source documents....Read More

/Docs/BloodBankingComputerValidationguidelines-ISBT-1202.pdfRead More

http://www.fda.gov/cber/blood/bldreginstr.htmRead More

/Docs/bldcellsep.pdfRead More

/docs/FDATraining-Inspectionofcomputersyschapter22c.pdfRead More

/docs/CBER-BPAC-Slides.pdfRead More

/docs/pmaautotest-CBER510-k.pdfRead More

/docs/Tissue-celldoc.pdfRead More

/Docs/BBexmatchFDAreviewChecklist.pdfRead More

/Docs/calaqstn.pdfRead More

Status of FDA permission requirements for Blood Bank establishment use of electronic crossmatch as of November 18, 1999: Because 21 CFR 606.151 requires a serologic crossmatch those hospitals (all hospitals) who wish to use the electronic crossmatch must apply for a variance to 21 CFR 606.151 (as allowed by 21 CFR 640.120) to gain written...Read More

/Docs/ISBT128Nov99.pdfRead More

/Docs/CBERnew510kparadigmslides4perpage.pdfRead More

/Docs/Bloodbank510kguidance.pdfRead More

/Docs/cberbloodestablishmentQAguideline.pdfRead More

/docs/CBER-BECS510kLetter1994.pdfRead More

http://www.fda.gov/cber/gdlns/bldestcomp.htmRead More