regulatory-affairs

If you’ve worked in medical devices for a while, the term Device Master Record or DMR probably feels like muscle memory. It’s been part of the regulatory vocabulary for decades, especially if you’ve worked with U.S. Food and Drug Administration (FDA) requirements.

It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? That's precisely what we will teach you in this blog! For an even deeper dive into the regulatory frameworks and quality expectations behind ISO 13485, …

In the medical device industry, quality management isn’t just about efficiency or customer satisfaction — it’s about patient safety. That’s why having a strong ISO 13485 QMS matters so much. You might think ISO 13485 is just for QA or regulatory affairs, but it touches every part of a medical device company, from production and supply chain to HR and commercial team. So, what is ISO 13485 quality…

Premarket approval (PMA) is the review process for medical devices by the US Food and Drug Administration (FDA) to ensure medical device safety and efficiency. With a PMA, the FDA poses rigorous requirements on medical devices. And without approval, manufacturers or device owners are barred from bringing their devices to market in the United States. All medical devices of Class III must receive P…

To legally market a medical device or IVD for human use in the US market, appropriate documentation must be submitted to the US regulatory authority, the FDA (Food and Drug Administration) Depending on the device risk class, the US regulatory submission can either be a 510(k), Premarket Approval (PMA), or a De Novo request. The type of regulatory submission you need is tied to the risk classifica…

Gene Therapy Clinical Trials Regulatory Affairs Regulatory and ethical issues of gene transfer are usually a secondary preoccupation of researchers. Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those…

I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them […] The post FDA wins big in key federal stem cell clinic court case appeared first on The Niche .

Over the last two years, China has updated some regulations on human genetic engineering and assisted reproduction and established a national committee to guide and supervise bioethics nationwide. But there are legal gaps in some of the regulations and tension between competing values: the desire to encourage new research and to potentially inhibit it by imposing stricter ethics regulations. The …

The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways […] The post One size doesn’t fit all? FDA may soften some cell therapy …