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How to prepare your medical device company for an FDA inspection

The FDA has arrived at your premises. What is your reaction? Are you ready? If you’re lucky, the FDA might have announced that they’re coming, but otherwise, they may turn up at any time. This means your company needs to be prepared at all times to go through an inspection. Here are some of the issues that we commonly see medical device companies trip over: Be prepared! People often hear that an inspection will happen, but don’t really believe it. Inspections are mandated, particularly for Class II or III medical devices. You will be inspected and the inspection may or may not be announced...

Webinar - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Webinar Materials Presentation (WMV - 253.6MB) Printable Slides (PDF - 292KB) Transcript (PDF - 249KB) On Tuesday, October 10, 2017, from 1:00-2:30 PM EST, the FDA will host a webinar for industry interested in learning more about the final guidance document “ Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices .” This guidance is applicable to all devices, as that term is defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act); including software that meets the definition of a device. This guidance clarifies how the agency...

FDA Finalizes Guidance on Medical Product Classification

On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues . This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues, such as the request for designation (RFD) process. The guidance combines and finalizes two draft guidance documents from 2011: Classification of Products as Drugs and Devices and Additional Product Classification...

Etude -
Diabète de type 1 : la pompe à insuline plus sûre que l’injection manuelle

Dans une étude publiée dans le JAMA , des chercheurs se sont demandé lequel de ces deux outils médicaux permettait le meilleur équilibre de taux de sucre dans le sang chez les enfants et jeunes adultes (moins de 20 ans). Ils ont conclu que la pompe à insuline entraînait une diminution, à la fois des hypoglycémies sévères, et des acidocétoses diabétiques, révélatrices d’hyperglycémie. L’équipe a comparé deux groupes de 9.814 individus chacun. Ils ont fait en sorte qu’à chaque patient sous pompe à insuline, soit associé un patient utilisant les injections manuelles d’insuline, avec les mêmes...

International -
Does Your Product Need a More-Flexible Sterilization Cycle?

A process control system for EtO sterilization chambers could give medical device companies "precise" control. Customers access securely their own chamber simulator via the Internet. The hosted simulator system resides on Konnexis servers behind Advanced CISCO firewall. Each customer has a dedicated database. Drug-coated products and other novel materials are presenting some unique challenges for EtO sterilization. “These products need more flexibility than a traditional cycle can provide,” Peter Veselovsky, president of Konnexis, told MD+DI. Sterilization of these newer products often...

Brazil -
ANVISA Officially Publishes Brazilian GMP Certification Process Changes

Brazil’s ANVISA has published updated BGMP certification rules allowing for desktop reviews instead of on-site inspections. The new BGMP requirements apply to Class III and IV device registrants able to provide adequate technical documentation for review. A Normative Instruction from ANVISA is anticipated that will provide additional details on how the new BGMP certification process will work...

Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices. Owen Faris, clinical trials director at the Center for Devices and Radiological Health (CDRH), said the opportunity to engage with patients goes beyond using patient reported outcomes (PROs) and patient preference information (PPI) in regulatory decision-making. According to Faris, patients should be engaged "at the very beginning when we're thinking about what technologies need to be...

International -
An Unusual Business Model

Naglreiter Medical Device Development Organization uses a novel approach to shorten the timeline between medical device concept and device submission. In the wide field of incubators, accelerators, co-working and wet lab spaces, and venture capital, Naglreiter Medical Device Development Organization (NMDDO) occupies a unique niche. The company, based in Miramar, FL, was started with the goal of reducing the time and resources that go into building a new medical device company or developing an innovative medical technology. Weeks or months, as well as millions of dollars can go into finding or...

Europe -
Phtalates et Dispositifs Médicaux

Commission Européenne – SCHEER : demande de création de lignes directrices relatives à une évaluation bénéfice-risque de la présence de phtalates CMR (cancérigènes, mutagènes, toxiques pour la reproduction) ou perturbateurs endocriniens dans certains dispositifs médicaux .

France -
Création d’un comité scientifique sur la cybersécurité des logiciels dispositifs médicaux

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a créé le premier comité scientifique spécialisé temporaire (CSST) sur la cybersécurité des logiciels dispositifs médicaux (DM). Les experts externes qui le composent sont chargés de proposer des recommandations pour garantir un niveau minimum de sécurité des logiciels utilisés dans le domaine médical face aux menaces de malveillance numérique. Un nombre croissant de dispositifs médicaux, qu’ils soient utilisés par des professionnels de santé à l’hôpital ou à domicile par des patients, sont aujourd’hui connectés. Ils...



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