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FDA strikes again with guidance documents « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/08/24/fda-strikes-again-with-guidance-documents
The Common Sense approach to Regulatory Affairs. FDA strikes again with guidance documents. Last week, the US Food and Drug Administration (FDA) rolled out three new draft guidances continuing its efforts to implement the plan of action for 510(k) and Science recommendations. The intent of this blog is to give a background for the requirement of these guidances and to provide a short preview of its scope. Highlights of the individual guidances will be addressed in later blogs. Issued August 16, 2011).
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About « Regulatory Affairs Buzz
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The Common Sense approach to Regulatory Affairs. This blog is intended for regulatory affairs and quality assurance professionals who are on the lookout for the latest industry news, solutions to quality problems, compliance case studies, etc. We’d like this blog to serve you. Please send us. Any thoughts you wish to offer on how we might improve it. This blog is provided as a service of Common Sense Systems. Leave a Reply Cancel reply. Enter your comment here. Address never made public).
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Esterilización | Red de Tecnologías Sanitarias
http://www.tecnologias-sanitarias.com/esterilizacion
34932998532 - Red Tecnologias Sanitarias. Calidad EN ISO 13485. Gestión de Riesgos EN ISO 14971. Biocompatibilidad EN ISO 10993ff. Software Médico y Apps EN I62304. Aptitud de Uso EN 62366. Tecno-med Consultores tienda online Web formación. Web tecnico responsable web guías MEDDEV web red tecnología sanitaria.
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Switching Notified Bodies « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/08/26/switching-notified-bodies
The Common Sense approach to Regulatory Affairs. All characters and references used in this story are purely fictional. They verified the current CE certificate to find that the certificate was valid for another 2 years. So it was concluded to switch Notified Bodies from A to B, while the company still continued to market their product in EU. Notified Body A was unhappy that STP dropped them for another company. They dragged their feet and became unresponsive when STP approached them to interact with...
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August « 2011 « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/08
The Common Sense approach to Regulatory Affairs. Monthly Archives: August 2011. Risk Based Approach to Monitoring Clinical Investigations. The US Food and Drug Administration (FDA) issued draft guidance on August 30, 2011, which is intended to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products and devices. The goal of this guidance is to enhance human subject protection and quality of clinical trial data.
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Risk Based Approach to Monitoring Clinical Investigations « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/08/31/risk-based-approach-to-monitoring-clinical-investigations
The Common Sense approach to Regulatory Affairs. Risk Based Approach to Monitoring Clinical Investigations. The US Food and Drug Administration (FDA) issued draft guidance on August 30, 2011, which is intended to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products and devices. The goal of this guidance is to enhance human subject protection and quality of clinical trial data. FDA encourages greater reliance on.
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510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/08/22/hello-world
The Common Sense approach to Regulatory Affairs. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device. The US Food and Drug Administration (FDA) issued a draft guidance on July 27, 2011, to provide manufacturers clarifications on when to and when not to, submit a premarket notification submission, 510(k), for changes or modifications made to previously cleared medical device. The types of modifications addressed in this draft guidance include:. The guidance doe...
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Switching Notified Bodies – The Analysis « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/08/30/switching-notified-bodies-the-analysis
The Common Sense approach to Regulatory Affairs. Switching Notified Bodies – The Analysis. The Notified Body you choose serves as your partner. You are free to change them for any reason. The process to address changes and any situations resulting from the change should normally be included in the contract between the Notified Body (NB) and the manufacturer. Here are some of the important aspects STP overlooked while switching NBs. In STP’s case no such date was agreed upon with Notified Body A. 4 The ma...
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September « 2011 « Regulatory Affairs Buzz
https://alwaysincompliance.wordpress.com/2011/09
The Common Sense approach to Regulatory Affairs. Monthly Archives: September 2011. Intended Use Vs Indications for Use. The meanings of Intended Use and Indications for Use have very specific implications when fulfilling FDA requirements. FDA defines Intended Use as:. A change to Intended Use warrants a new submission when it could significantly affect the safety or effectiveness of the device. FDA defines Indications for Use as:. The key regulatory terms intended use and indications for use are poorly d...
