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Devine Guidance

Class I Devices in the United States

By Dr. Christopher Joseph Devine

…information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm9 IMPORTANT NOTE: Only the class I devices with an asterisk…

…information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm9 IMPORTANT NOTE: Only the class I devices with an asterisk…

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Devine Guidance

Failure to Define

By Dr. Christopher Joseph Devine

…readers already know, Dr. D loves to pontificate about regulatory compliance and the need to have documented evidence to support claims of compliance. In fact, Dr. D’s rants on compliance…

…readers already know, Dr. D loves to pontificate about regulatory compliance and the need to have documented evidence to support claims of compliance. In fact, Dr. D’s rants on compliance…

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Devine Guidance

Product Seizure

By Dr. Christopher Joseph Devine

…FDA Website. Retrieved July 18, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108893.htm Rossetti, A. (2008, December). Shelhigh: anatomy of an FDA medical device product seizure. The Legal Examiner.  Retrieved July 18, 2013, from http://westpalmbeach.legalexaminer.com/medical-devices-implants/shelhigh-anatomy-of-an-fda-medical-device-products-seizure/…

…FDA Website. Retrieved July 18, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108893.htm Rossetti, A. (2008, December). Shelhigh: anatomy of an FDA medical device product seizure. The Legal Examiner.  Retrieved July 18, 2013, from http://westpalmbeach.legalexaminer.com/medical-devices-implants/shelhigh-anatomy-of-an-fda-medical-device-products-seizure/…

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Devine Guidance

Detention

By Dr. Christopher Joseph Devine

…masks can be categorized as a “fungible” (look-it-up) commodity; however, approval/clearance is still required to enter these devices into commerce in the United States. Just maybe, someone at Lucky might…

…masks can be categorized as a “fungible” (look-it-up) commodity; however, approval/clearance is still required to enter these devices into commerce in the United States. Just maybe, someone at Lucky might…

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Devine Guidance

Calibration

By Dr. Christopher Joseph Devine

…electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, your firm did not…

…electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, your firm did not…

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Richard Sokolov, Director-Product Development, ide+
MEDdesign

Form versus Function in Medical Design

By Richard Sokolov, W.M. (Willem Mees) van der Bijl

…the technology itself. Form versus usability New solutions and innovations are being developed and introduced at an increasing speed. The products we use keep changing their appearance and new applications…

…the technology itself. Form versus usability New solutions and innovations are being developed and introduced at an increasing speed. The products we use keep changing their appearance and new applications…

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Devine Guidance

Device History Record

By Dr. Christopher Joseph Devine

Folks, if an event or activity is not documented in writing, it never happened in the eyes of our friends at FDA. When it comes to retaining accurate records reflecting…

Folks, if an event or activity is not documented in writing, it never happened in the eyes of our friends at FDA. When it comes to retaining accurate records reflecting…

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MEDdesign

Designing Connected Health Services

By Montana Cherney, Stefan Moritz

“Connected Health is the coming together of technology, devices, and people to enable increased access, improved care, lower costs and better outcomes.” – Montana Cherney, Connected Health – The User-Driven…

“Connected Health is the coming together of technology, devices, and people to enable increased access, improved care, lower costs and better outcomes.” – Montana Cherney, Connected Health – The User-Driven…

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Devine Guidance

Device Master Record

By Dr. Christopher Joseph Devine

…Form 483 Observations for failing to comply with §820.181 (Device Master Record). In some cases, the failure to comply with §820.181 is finding its way into warning letters, a nice…

…Form 483 Observations for failing to comply with §820.181 (Device Master Record). In some cases, the failure to comply with §820.181 is finding its way into warning letters, a nice…

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Devine Guidance

Receiving Inspection

By Dr. Christopher Joseph Devine

…supplier is not so good, you can tighten the sampling, while you begin the search for a new supplier. If the quality is excellent, you may want to consider skip-lot-inspection….

…supplier is not so good, you can tighten the sampling, while you begin the search for a new supplier. If the quality is excellent, you may want to consider skip-lot-inspection….

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