Aug 17, 2017

Nuts and Bolts of 510(K) Submissions

There's no getting around the
rules for 510(k) submissions.

by Rob Packard


Medical Device Academy, Inc.

A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

The current device classification system consists of three-letter product codes for each device type. Each classification is designated as Class I, Class II or Class III. Class I devices are considered low risk and require only “general controls.” Class II devices are considered moderate risk and require “special controls.” Finally, Class III devices are high-risk devices that typically require a clinical study to demonstrate safety and efficacy. The FDA only “approves” these Class III high risk devices. All other device classifications are not “approved” by the FDA via the pre-market approval (PMA) process.

Aug 15, 2017

What Is a Quality Control System and How Can an EQMS Improve On It?

Although it may identify problems and
facilitate ways to resolve them, a quality
 control system alone does not ensure quality.

by David R. Butcher

Staff Writer


For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two are not necessarily interchangeable

Aug 14, 2017

Regulatory Strategies for AI and Emerging Technologies

AI and machine learning are at an early
stage but offer great potential
for improving medical care.

by Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc.


Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.

Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.

When powerful new technologies emerge, unbridled excitement often reigns.  The possibilities are endless and markets are undoubtedly huge.   Artificial intelligence and machine learning in medicine are at an early stage and the potential to improve medical care is solidifying.  Many opportunities are being pursued including enhancing and supporting the decision-making process of physicians, individualizing patient care with precision medicine and using near real-time information to improve care.

Aug 8, 2017

6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

by Alex Butler

Manager, Medical Device Solutions


Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers with as many opportunities as challenges.

This excerpt from my recent MDDI Device Talk blog post highlights some of the advantages and growing pains to keep in mind if you are considering making the move into the combo product space in 2017.

Aug 3, 2017

Is The 510(k) Process As Worthless As The Federal Courts Seem to Believe?

It is time for the Supreme Court
to remedy the Federal Courts'
understanding of the 510(k) process.

by Jeffrey K. Shapiro

Hyman, Phelps, McNamara, P.C.

Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says it does (p. 44). Device makers and those of us who practice in this area know how burdensome and extensive this process can be. It requires device makers to provide extensive preclinical safety and effectiveness data for FDA’s review. Depending upon the type of device, FDA may also require clinical data. We wrote a Food and Drug Law Journal (FDLJ) article in 2014 describing the evolution of the 510(k) program and its current‑day rigor.

Aug 1, 2017

UDI as Med Device Product Tracking Software (Why That’s a Good Thing)

by Cindy Fazzi

Staff Writer

When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?