Real-World Evidence for Medical Device Regulatory Decision-Making

As health data continues to become increasingly available, opportunities are arising for the use of data to support medical device decision making. FDA has recognized this and is creating new paradigms to use real-world data (RWD) to support regulatory decision-making for medical devices. RWD sources such as registries, EHRs, and administrative healthcare claims databases provide Continue Reading »

Medical Device Regulation Book Suggestions: What Every Entrepreneur Should Know

Over the years, we have worked with many small companies who are interested in developing medical devices. Eventually, these companies encounter the regulatory paradigm established by the Food Drug and Cosmetic Act and/or the Medical Device Directive. Hopefully a first encounter with these regulations is part of a business plan, but sometimes this is not Continue Reading »

FDA’s New ISO 10993-1 Biocompatibility Evaluation Guidance

On June 16th, 20016, FDA published a final guidance on biocompatibility evaluation called, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Special consideration should be paid to Attachment A of the guidance document which provides a framework for the development of Continue Reading »

FDA’s Pre-Submission Program

FDA’s Pre-Submission (Pre-Sub) Program allows for sponsors to meet with FDA to get feedback on medical device submissions (e.g., IDEs, PMAs, HDEs, and 510(k)s). The main purpose of the program is to provide the sponsor with a mechanism to obtain feedback from FDA prior to an IDE or marketing application, allowing a sponsor to understand Continue Reading »

Is It a Medical Device?

Often, a company wonders if their product is a medical device and what that means for them. What are the FDA requirements for a particular product and how difficult will it be to get the FDA’s blessing? To discover this information, the first step is to look at the encompassing definition of a medical device and question Continue Reading »

Mobile Medical Apps

The many benefits that technology – and particularly information technology – provides to other industries has yet to be realized in healthcare, although it is the popular belief that the adoption and use of Healthcare Information Technology (HIT) will have a large positive effect on the clinical outcomes and the economy. Recent legislation has attempted Continue Reading »

New LDT Regulations on the Horizon

Technological advances are leading to the increased relevance of personalized medicine and genomic testing. Over the next few decades we will see a rapid development of these technologies which will result in improved medicinal efficacy and a reduction in the overall economic burden of the healthcare costs in the US. The FDA is aware of Continue Reading »

Notified Bodies’ Unannounced Audits

On September 24, 2013 the European Commission published a recommendation that Notified Bodies perform unannounced audits in addition to annual and recertification audits. Unannounced audits are already being performed by Notified Bodies and will become common practice over the next couple of years. If you would like to read more about the recommendation, follow the Continue Reading »

Approval to Market or Distribute a Medical Device in the US: A Brief Overview

Gaining market approval is not easy. Commercializing a product in the United States requires a significant amount of time and money. In addition, device manufacturers must navigate the complex and time-consuming requirements enforced by the Food and Drug Administration (FDA). When attempting to market a new device, a manufacturer must assess the regulatory requirements and Continue Reading »