Medical Technology and Life Sciences Publications

FDA, Products Liability, Regulatory and Compliance, Article

Under the Watchful Eye of the FDA: What do FDA Warning Letters Tell Us?

Kevin L. Ong, Ph.D., P.E.1; Joshua White, Ph.D.2 1 Principal Engineer, Biomedical Engineering practice, Exponent, Inc., Philadelphia, PA 2 Senior Associate, Biomedical Engineering practice,...

6 minute read

FDA, Risk Management, Products Liability, Supply Chains, Clinical Trials, Regulatory and Compliance, Article

IMDA: Together We're Better

Being the owner of a small, entrepreneurial company can be exhilarating. You write your own ticket, set your own direction. But it can also be daunting. After all, there are no corporate coffers...

2 minute read

FDA, Risk Management, Products Liability, Supply Chains, Clinical Trials, Regulatory and Compliance, Article

Employee Participants In Clinical Trials

Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate...

6 minute read

FDA, Products Liability, Series: Ask an Expert, Regulatory and Compliance

Warning Letters & Products Liability

Question: If my company gets a Warning Letter from the FDA, how will it affect our products liability litigation? Answer: A company’s first priority is to deal with the FDA’s...

1 minute read

FDA, Risk Management, Series: Risk Management 101, Regulatory and Compliance

Quality System

The term "quality" refers to a medical device's fitness for its intended use. To ensure quality, the Food and Drug Administration (FDA) requires the manufacturers of medical devices to...

2 minute read

FDA, Risk Management, Products Liability, Supply Chains, Regulatory and Compliance

Effective Supply Chain Management for Medical Device Shipments

Medical device manufacturers face a daunting challenge in today's market. In addition to understanding stringent government regulatory requirements and FDA-mandated current Good...

4 minute read

FDA, Risk Management, Clinical Trials, Emerging Growth, Informed Consent, Series: Risk Management 101, For Entrepreneurs, Regulatory and Compliance

FDA Requirements for Informed Consent Forms

Obtaining informed consent from participants in a clinical trial study is vital. A key document in the informed consent process is the informed consent form. Food and Drug Administration...

2 minute read

FDA, Risk Management, Claims and Litigation, Regulatory and Compliance

Best Practices for Responding to Form-483s and Warning Letters

Perhaps no enforcement actions are dreaded more by life science companies than FDA Form-483s and Warning Letters. This is not only because these actions put the company on the FDA’s radar...

4 minute read

FDA, Products Liability, Blood and Tissue (HCT/Ps), Regulatory and Compliance

Human Tissue Products

Products or product components that are composed of human cells and tissues, such as stem cells, are at the forefront of medical technology. They may also receive unique treatment under...

3 minute read

FDA, Risk Management, Series: Risk Management 101, Regulatory and Compliance

When is a Drug or Device Misbranded?

The Federal Food, Drug, and Cosmetic Act ("FDCA") is a federal law that is a primary source for many rules that impact the pharmaceutical and medical device industries. The FDCA's intent...

1 minute read

Regulatory and Compliance

Filtered on