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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

While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. In Canada the blood establishment is regulated. Computer systems used in donor establishments are not considered medical devices and are regulated through the establishment licensing process. Unlike with the...Read More

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FDA has been investigating putting together information on hazards of various types of devices as an aide to both FDA and industry. Sandy Weininger at CDRH has established a forum for dissemination of information on this project. If you are interested in participating or receiving updates on this effort send email to office@softwarecpr.com or directly...Read More

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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

While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. According to the Danish Competent Authorities the European Union (EU) approach is that equipment for blood banks including transfusion and information systems with clinical data about the donors, blood...Read More

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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part...Read More

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FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”. This notice also: officially withdraws not only all earlier draft Part 11 guidance documents but it also withdraws the Part Compliance Policy guide formally announces FDA’s intent to reexamine its...Read More

Today, FDA issued a new Part 11 guidance draft that reduces the scope and burden of Part 11 significantly.  It essentially suspends enforcement on legacy systems existing prior to the rule’s effective date in 1997 and eliminates: enforcement related to audit trails, electronic copies, and maintenance of electronic records by focusing on meeting the intent...Read More

ADVAMED and NEMA sent a letter to Dr. Feigal (Director of FDA’s Device Center) raising concerns about Part 11 based on a recent meeting with FDA. They are objecting to the return of Part 11 responsibility to the drug center with no formal device center involvement and the potential that the drug center will issue...Read More

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On Nov 12, 2002 FDA released its 5th draft Part 11 guidance “Electronic Copies of Electronic Records”. The date in the document itself is August 2002. This draft is at the link provided. It addressed content, format, and integrity requirements for provision of records in electronic form to FDA.It: – allows that electronic copies do...Read More

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