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FDA

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Tag: FDA
13Jul 2024
FDA, EU, EU MDR, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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12Jul 2024
General Information Cubicdesignz Comments: 0

Definition of a Medical Device around the global market

What is a Medical Device? The simplest definition of a medical device is a product used for treatment except for medicines. It is imperative to understand if the product classifies as a medical device and apply the regulations after defining it properly. An essential aspect of defining a medical device is its intended use. Intended use is the purpose of the device specified by the manufacturer. In this article, we have brought up the definition of “medical device” for a few major countries....
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12Jul 2024
FDA, USA Cubicdesignz Comments: 0

Current Good Manufacturing Practices (cGMPs) of the FDA

The FDA introduced current Good Manufacturing practices (cGMP) to maintain a system that provides proper design, monitoring, and control of manufacturing processes and facilities. The cGMP standards ensure products’ identity, strength, quality, and purity by requiring manufacturers to maintain proper control over their manufacturing processes. This system helps the manufacturer avoid as many failures and errors as possible. The “C” in cGMP refers to “current,” which...
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12Jul 2024
FDA, USA Cubicdesignz Comments: 0

De Novo Request | FDA

The De novo request is a simpler marketing pathway to classify novel medical devices that provide a reasonable assurance of safety and effectiveness for the intended use and do not already have a predicate device on the market. FDA also declares that the devices marked as Class I or II as per De novo request can be further used as a predicate device for future premarket 510(k) notifications. De Novo Request Procedure There are two ways to submit a De Novo request to the FDA for a risk-based eval...
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12Jul 2024
EU, FDA, Regulations, USA Cubicdesignz Comments: 0

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are connected to the Internet, hospita...
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12Jul 2024
FDA Cubicdesignz Comments: 0

Post Market Surveillance Plan – FDA

Post Market surveillance requirements are set out in Title 21 Code of Federal Regulation (CFR) Part 822. This section aims to put an adequate post-market surveillance authority into practice to increase the possibility that post-market surveillance (PMS) plans will result in valuable data gathering. These data can show unanticipated adverse events, the actual frequency of anticipated adverse events, or other details important for public health protection. FDA will assign a post-market surveillan...
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12Jul 2024
EU MDR, FDA Cubicdesignz Comments: 0

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Facing a medical device audit can be daunting, but with meticulous preparation and strategic responses, companies can turn this challenge into an opportunity for building a robust quality system. Tips for Mastering Medical Device Audits This article provides a detailed roadmap for mastering medical device audits, covering essential steps from internal audits to adeptly handling regulatory findings. 1. Demystifying Audits Understanding the fundamental concepts behind medical device audits is cruc...
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16May 2024
Cosmetics admin Comments: 0

Cosmetics Product Recall under FDA

Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as seizure. FDA strongly advises businesses to familiarise themselves with all of the regulations, including the elements of a recall strategy, in 21 CFR Part 7. What is the FDA’s responsibility in a recall of Cosmetics Product? The FD...
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05Feb 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin Comments: 0

Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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05Feb 2024
EU, EU MDR, FDA, Regulations, USA Cubicdesignz Comments: 0

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
Read More