Latest medical device Industry blogs & news | Operon Strategist
ISO 18562

ISO 18562 VOC and Particle Testing for Medical Devices

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ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The regulatory approval process for medical devices is complex and not always well defined. The Food and Drug Administration (FDA) is the federal agency responsible for the regulatory oversight of medical devices in the U.S. Most medical device premarket reviews conducted …

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Trump directs USTR to take up pricing of pharmaceuticals, medical devices

Trump directs USTR to take up pricing of pharmaceuticals, medical devices

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President Donald Trump today directed his top trade negotiator to strongly take up with all countries the fixing of prices of American pharmaceuticals and medical devices. Describing such fixing of prices by other countries as unjustified and done at the expense of America’s research and development, Trump said that the US can longer tolerate such behaviour …

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Regulatory Education for Industry (REdI) Spring Conference 2018

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The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA), and Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) are pleased to announce a co-sponsored event developed just for you the Regulatory Education for Industry conference. The Regulatory Education for Industry (REdI) Conference is …

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Final Guidances On Next Generation Sequencing In Vitro Diagnostics

最终指导下一代测序|Vitro Diagnostics

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On Thursday, May 24, the FDA will host a webinar about two finalized guidance designed to enhance collaboration among researchers, and drive the efficient development of novel next-generation sequencing (NGS) based tests. Next-generation sequencing (NGS), massively parallel or deep sequencing are related terms that describe a DNA sequencing technology which has revolutionized genomic research. DNA sequencing is …

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Regulation Of Imaging Equipment Strengthen By Government

Regulation Of Imaging Equipment Strengthen By Government

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The government has decided to tighten the reins on ultrasound machines and similar imaging equipment in order to prevent companies from importing these products into India without proper registration. The move is also expected to ensure that these products follow high-quality standards and are easier for the government to track in order to prevent abuse …

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Extension of CDSCO WHO’s GMP certificate

Extension of CDSCO WHO’s GMP certificate

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In a move to improve ease of doing business, India is increasing the validity of the World Health Organisation(WHO) Good Manufacturing Practices (GMP) certificate to three years. The CDSCO WHO GMP certificate was earlier valid for two years, said Drug Controller General of India Eswara Reddy during the 6th annual International Exhibition of Pharma and Healthcare (iPHEX) on Tuesday. The measure would also …

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Guidance for Multiple Function Devices

FDA Releases Draft Guidance for Multiple Function Devices

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FDA has issued a draft guidance for Multiple Function Devices to clear up its policy for products that have more than one function. The draft, Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff, is related to Digital Health and the 21st Century Cures Act. It suggests that …

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De Novo Pathway

Opportunity for Device Manufacturers on De Novo Pathway Extension

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When FDA added De Novo Pathway as an alternative pathway for medical device manufacturers seeking Class I or Class II classification of their novel products in 1997. Even though medical device products are automatically classified as a Class III device. The FDA’s initial De Novo process retained the application requirements whereby firms were first to submit a …

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Medical Device Accessories

Medical Device Accessories Guidance | Food Drug and Cosmetic Act

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The FDA issued Medical Device Accessories –Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) for combination products. The #guidance document offers welcomed clarity on the role of an “accessory” and its regulatory relationship to its parent device. As always, guidance documents are …

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General Data Protection Regulation

General Data Protection Regulation Effect On Medical Devices | EU

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The EU’s General Data Protection Regulation(GDPR) will go into full effect on May 25, 2018. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves. The basic concept is that your patient’s data is no longer yours to process …

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