Dr. Frestedt joins this episode to discuss the structure of the new EU-MDR regulations coming into effect. Download the episode on Apple iTunes
In this episode, the Frestedt Incorporated team discusses their recent experience with writing 14 Clinical Evaluation Reports (CERs), including the purpose and scope of these reports and some tips to address common pitfalls they observed during CER writing. Links to resources in this episode: Med Dev 2.7.1 http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf EN ISO 14971:2012 (link to purchase; not available for free online) http://shop.bsigroup.com/ProductDetail/?pid=000000000030268035 PubMed literature database http://www.ncbi.nlm.nih.gov/pubmed FDA 510(k) database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm FDA […]
A review of the standard specifications and testing for Luer lock connections in devices used in the gastrointestinal systems. Learn about the FDA safety concerns with these devices and suggested testing to show risk has been designed out of the product. Information on the FDA safety concerns for Luer lock devices: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery FDA Final Guidance on Safety Considerations to Mitigate the Risks of Misconnections with Small Bore connectors Intended […]
Dr. Joy Frestedt explains why every company can and should be able to carry out clinical trials to ensure safety and demonstrate efficacy of their product. Low-risk clinical trials are discussed, including claims substantiation trials, and Dr. Frestedt gives examples of some considerations to make clinical trials accessible, affordable, and appropriate for the needs of your company. .
An overview of the FDA Draft Guidance on cGMPs for Combination Products, released in January 2015. Learn how to decide which GMPs win when working with devices where both drug and device regulations apply. Link to FDA Draft Guidance: Current Good Manufacturing Practice Requirements for Combination Products http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf .
In this first episode, Science of Compliance welcomes listeners with an interview of the Frestedt Incorporated staff to discuss what it’s like to work in the clinical trials, regulatory affairs, and quality systems fields. Additionally, CEO Joy Frestedt, PhD, gives some details of her journey from being a one-woman entity to managing her own small (but rapidly growing) consulting firm. Learn more about Frestedt Incorporated and Alimentix at the […]
A summary of two FDA webinars discussing Unique Device Identifiers (UDI) and Global Unique Device Identifier Database (GUDID). Learn what information is incorporated into UDIs and what devices are affected by UDI and GUDID registration. Links referenced in this episode: UDI 101 Presentation Slides: http://www.fda.gov/downloads/Training/CDRHLearn/UCM430216.pdf Transcript: http://www.fda.gov/downloads/Training/CDRHLearn/UCM431248.pdf Getting Ready for GUDID Presentation Slides: http://www.fda.gov/downloads/Training/CDRHLearn/UCM430217.pdf Transcript: http://www.fda.gov/downloads/Training/CDRHLearn/UCM431251.pdf .
A play-by-play of the latest FDA CDRH guidance CDRH entitled “General Wellness: Policy for Low Risk Devices.” Learn what defines a low-risk general wellness product, and how to tell if YOUR product falls under this guidance. Comments on this draft are open for 30 days starting January 20, 2015. Call Frestedt Inc. if you have questions about this guidance and want to discuss your product. To read the full guidance, […]