By

Jordan Pate
FDA Center for Biologics Evaluation and Research released SOPP 8116 “Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff” Version #4 Effective Date: August 10, 2010. This describes their approach to using electronic signatures for certain regulatory approvals (including correspondence and premarket submissions) and is based on applying each person’s network profile identification via...
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The key guidance document from FDA regarding the software documentation required in a premarket submissions for FDA including 510(k)s, PMAs, and IDEs is the “Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005  
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FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”.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...
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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...
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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...
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WITHDRAWN BY FDA Feb 2003 as not representative of their current thinking. FDA has released it as a draft validation Guidance on Part 11 Electronic Records; Electronic Signatures. These guidance documents were developed by FDA’s Part 11 Compliance Committee. This is a draft, and industry comments will be important in shaping the final guidances. Submit...
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The Validation Times Vol III, No. 5 May 2001 reported that James McCormack of FDA : 1. Indicated that the first two FDA Part 11 Guidances may be issued as early as June 2001. These would be the Glossary and Validation guidances. Scope would not be addressed. Other guidances would follow over a period of...
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The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software: “i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem: Stewart Crumpler Office...
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Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee. As of January 2001: 1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final. 2. FDA has suspended...
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The Device Quality System Regulation (GMP) explicitly requires signatures in the following places: The sections of the regulation which specifically require signatures are: · Sec. 820.30 Design controls.c & d · Sec. 820.40 Document controls a & b · Sec. 820.75 Process validation a · Sec. 820.80 Receiving, in-process, and finished device acceptance d&e. ·...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

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