Showing items tagged as FDA

  • FDA’s New 510(k) Pathway Highlights Safety and Performance Data

    October 6, 2020 By David Jensen, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.

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  • GCP Compliance Hack: How to Avoid the Most Common Warning Letter Trigger

    September 29, 2020 By James Jardine, Staff Writer

    The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.

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  • Is Your Design History File Prepared for an FDA Inspection?

    September 25, 2020 By David Butcher, Staff Writer

    The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.

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  • FDA Sets Out to Curb Data Integrity Violations With Guidance on Data Handling

    August 7, 2020 by David Jensen, Staff Writer, MasterControl

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in regulated product manufacturing.

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  • Having a Good Quality Culture Improves Your Data Integrity

    June 30, 2020 By Susan Schniepp, Distiguished Fellow at Regulatory Compliance Associates, Inc

    Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.

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  • What Verification and Validation Activities are Required for a First in Human Study?

    June 23, 2020 By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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  • FDA 21 CFR Part 11 and Predicate Rules: What You Need to Know

    June 11, 2020 By James Jardine, Staff Writer, MasterControl

    Through FDA 21 CRF Part 11, the U.S. Food and Drug Administration (FDA), established that electronic records and signatures are as valid as paper records and handwritten signatures. Maintaining compliance is dependent on your understanding of the FDA predicate rules that apply to your company.

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  • Weighing FDA's Response to the COVID-19 Pandemic

    May 19, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    The rapid global spread of the coronavirus caught many world governments and health authorities off guard. Gina Guido-Redden, co-founder and COO of Coda Corp USA, offers a comprehensive review of the how the U.S. Food and Drug Administration (FDA) has responded thus far to the pandemic under 21 CFR.

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  • FDA Trending Toward Cloud Technology to Drive Innovation

    April 16, 2020 by David Jensen, Staff Writer, MasterControl

    The life sciences industry is experiencing a surge of scientific and technology advances. However, there remains a sizeable gap between the discoveries and the technologies needed to translate them into useful therapies. Recently, the U.S. Food and Drug Administration (FDA) introduced a Technology Modernization Action Plan (TMAP) to foster modernization in the life sciences industry in order to more efficiently expedite scientific innovation.

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  • Working Together to Beat COVID-19

    April 2, 2020 by Sarah Beale, Staff Writer, MasterControl

    At this point, COVID-19 has touched everyone’s life in some way. While we’re still struggling to keep up with the pandemic, many of our customers are undergoing initiatives to test and/or treat the virus.

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  • Surge of Data Integrity Violations Irritating the FDA

    December 12, 2019 by David Jensen, Staff Writer, MasterControl

    Regulatory agencies cannot feasibly review every process and every bit of data at every regulated company. This is why they rely on manufacturers to provide complete and accurate information in their submissions. Still, data integrity violations remain the most common reason why medical product companies receive Form 483s and warning letters. For this reason, life sciences companies seeking regulatory approval for products should expect to ramp up their data management efforts.

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  • 2019 Med Device Trends to Watch For: Regulatory Changes

    February 14, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    January 2, 2019 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

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  • De Novo Becoming Faster and Easier Pathway to Market

    October 25, 2018 by David Jensen, Staff Writer, MasterControl

    There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.

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  • Why the Cloud Is the Key to Easing Your Validation Burden

    August 16, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    If your organization spends several weeks or months performing software validation, you’re not alone. Most regulated companies do. But, Erin Wright, MasterControl’s validation product manager, said validation doesn’t have to be as burdensome anymore. The powerful cloud technology, combined with a risk-based approach, is the key to a faster and better validation process.

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  • Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    August 9, 2018 by David Jensen, Staff Writer, MasterControl

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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  • How to Gain Entry to Latin America’s Medtech Market

    August 7, 2018 by Julio G. Martinez-Clark, CEO, LATAM Market Access

    Don’t get bit by piranhas and crocodiles when entering Latin America’s lucrative $31 billion medical device manufacturing industry. Learn from a pro the tips, strategies and trends you’ll need to be successful in the golden medtech market in North and South America.

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  • Using a QMS to Qualify Your Suppliers

    August 2, 2018 by Sarah Beale, Staff Writer, MasterControl

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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  • Regulatory Barriers to Innovation for Startups

    July 31, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • Ensure Data Integrity With a Proactive Data Management Strategy

    July 24, 2018 by David Jensen, Staff Writer, MasterControl

    Data management technologies continue to evolve and improve the processes for collecting, storing and analyzing data. However, new technology rarely avoids growing pains. One dilemma regulated companies face with technology updates is maintaining data integrity. Regulatory guidelines for data integrity insist that all data and metadata remain intact and unaltered. This is a tall order when companies need to perform a large-scale data migration each time they update their data storage infrastructure. A good approach to effectively manage data and remain compliant with data integrity requirements is to develop a practical data management strategy around data storage and migration.

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