The Most Important Compliance Best Practices You Need to Know

The FDA’s latest rule on New Dietary Ingredient Notification has created confusion on when, who and how the submissions are to be done to the agency. This article details some of the most important issues addressed in the new rule.

When it comes to immunogenicity testing of biotech products and derivatives, a number of risk factors have to be considered. This article describes these risk factors and who should consider them during the testing process.

Automation often seems the best choice for medical device manufacturers in order to ensure that variations in processes are avoided and quality consistency is attained. However, automating blindly comes with high risks and therefore a number of steps must be taken to avoid such risks. In this article, Dev Raheja, a medical device quality expert, explains the risk management principles and processes that must be taken into consideration before implementing manufacturing automation.

Dietary supplements in the US are regulated by the FDA and USDA. Under the Dietary Supplements Health and Education Act of 1994 (DSHEA), the Office of Dietary Supplements at the NIH was created. This article discusses the cGMP issues that dietary supplement makers face and the best practices to overcome these.

Several surveys conducted in 2009 showed that around 61% of American adults get their health information from the internet. Around 79% of patients also believe that they learn more about medicines from the manufacturers’ social media channels.

This uptick in numbers of people who use the internet for more information on regulated products has forced the FDA to address the issue of using social media and the internet to disseminate information on regulated products.
 

How can various departments work together to ensure medical device design projects are executed efficiently and successfully? This responsibilitiy lies with the management - but what are the best practices that can be followed?

Dev Raheja, a renowned medical device quality expert, explains all in this article.

There’s been an uptick in the number of post-approval Phase IV or post-marketing studies in the pharmaceutical industry. This is mainly due to a spike in rare adverse events following the release of a drug into the market and corresponding increase in the number of product recalls by manufacturers.

How do you conduct a successful post-marketing study? Read on to find out.

What are FDA Pre-Approval Inspections or PAIs? How can you ensure your organization has a successful PAI? Read this article to learn what regulations apply for PAIs and best practices that all FDA regulated companies can follow for a smooth pre-approval inspection.

Proper documentation of all processes proves to the FDA that you are in full control of your operations. It’s become a legend in all industries regulated by the FDA but it is a mantra that companies should heed:

"If it’s not documented, it didn’t happen."

But what are the best practices for FDA compliant documentation? Read on to find out.

There are over a 1000 recalls of medical devices annually. What are the dangers that make medical devices harmful to the user? Dev Raheja, a renowned medical device quality expert, explains the types of dangers in medical devices in this article.

Can the Swiss Cheese Model be used to create medical devices that are safe and reliable?

Dev Raheja, a medical device quality expert, explains how this model offers a highly effective approach in understanding and preventing adverse events in medical devices.

The FDA has published a guidance document detailing which studies should be included in the clinical studies section of prescription drug labeling, how individual studies should be described, and what data should be presented. The guidance aims at making the clinical section labeling more useful, helping promote consistency in content and format across various drug product classes and indications.

This article describes the best practices to comply with the recommendations in this guidance.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions. This article gives the best practices for complying with the adverse reactions section of labeling for human prescription drug and biological products.

Usually Quality Assurance (QA) is looked upon as bearers of bad news. Then it is forced react with the CAPA (Corrective and Preventive Action) system which is always reactive. Instead, QA can be the bearers of good news by reporting which adverse events were proactively prevented by eliminating their root causes. This article, by renowned medical devices expert Dev Raheja, details the ways this can be achieved.

The FDA requires medical device manufacturers to submit reports in case of device malfunctioning. But when and how are these reports to be submitted? Which medical device malfunctions require reporting to the FDA?

This article describes the best practices that medical device manufacturers can follow in order to comply with medical device reporting to the FDA.

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects.

This article describes the best practices to be followed in order to comply with the FDA's new guidelines on adverse event reporting to IRBs.

The FDA has issued guidance on how to submit 510(k)s for changes to existing devices. This guidance details the types of significant changes that necessitate the need for submitting a 510(k).

This article describes the best practices that medical device manufacturers can follow in order to comply with this guidance.

Medical device recalls happen frequently due to faulty device design or usability. How can medical device manufacturers prevent medical device recalls? What are the best practices to be followed?

In this article, Dev Raheja, a recognized expert on medical devices, discusses the various kinds of recalls, how the FDA oversees these and how to prevent them.

IEC 80001 is an international standard for managing risks in IT networks using medical devices. Its aim is address issues of safety, effectiveness, data, and system security in the network. The standard defines the process and also defines responsibilities for each of the stakeholders involved. It recognizes that risk management should be applied throughout the lifecycle of the networks. 

This article discusses the best practices for medical device manufacturers to comply with this standard.

The Food and Drug Administration (FDA) receives spontaneous adverse event reports from health care professionals and consumers. A manufacturer, upon receiving an adverse event report from a patient or health care professional, has to send a report to FDA.  The U.S. Department of Health and Human Services (HHS) Food and Drug Administration Center for Biologics Evaluation and Research (CBER) has mandated reporting of adverse events and has issued guidance towards this end.

This article describes the best practices to be followed in the reporting of adverse events.