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?

Jul 28, 2017

Good Communication Skills are Key for Inspection Readiness

When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you will gather the requested data and forms, how prepared the facility is and with whom will the inspectors be interacting.

But you must also consider whether or not the personnel in the organization are properly prepared to communicate and interact effectively with the FDA investigator.  You want your personnel to be familiar enough with the processes and procedures of the inspection to provide the best possible impression .  In short, you need to help the quality assurance, auditing and operations teams understand what’s expected during a FDA and/or EU inspection. Of course, the best way to be ready for an inspection is for your company to have your processes, procedures and documentation under control and operating in a state of compliance with regulations.

Jul 25, 2017

Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

Patient recruitment for pediatric trials
is challenging but very necessary for
drug and medical device development.

by Jamie Arnott, Project Director


Caitlin Hirschman, Clinical Team Lead


When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

Jul 20, 2017

5 Trends Driving Disruption in the Med Device Industry in 2017

Connected devices for seniors
may allow them to age in place.

by Lisa Weeks

MasterControl Staff Writer

The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them.

#1 Other Business Sectors Will Continue to Disrupt the Space

Google and Apple may have led the charge, but we can expect to see other business sectors vying for a piece of the health care market in 2017. “As emerging technologies are further integrated into health care, more tech and non-traditional device companies will continue to enter the space,” according to Matt Lowe, an engineer who has successfully launched more than a dozen medical devices and serves as executive vice president of MasterControl. “To stay competitive, established players will have to gain knowledge of these new technologies, or partner with companies that already have it.” 

Jul 18, 2017

How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

A company’s ROI from an online training
program can be substantial and immediate!

by Greg Peckford

Founder, Quality Career Advancement

Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

Jul 13, 2017

FDA Favors Collaborative Approach to Medical Device Cybersecurity

Implement cybersecurity at the grassroots
level of medical device development

by David Jensen

MasterControl Staff Writer

Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the subject at MedTech Intelligence’s conference on Medical Device Cybersecurity.

Suzanne Schwartz, associate director for science and strategic partnerships at the Center for Devices and Radiological Health (CDRH), talked at length about the FDA’s approach to cybersecurity at the conference held in Washington, D.C., March 23-24. Schwartz referred to medical cybersecurity as an ecosystem, which encompasses every organization involved in designing, manufacturing and using medical devices.

Jul 11, 2017

Developing a Quality System on a Managed Budget

Budget Constraints Constantly Evolve

Through an Organization's Life Cycle

by Keith Matthews

Director, Quality Systems 

Regulatory Compliance Associates Inc.

Insights on driving value from staffing, automation and continuous improvement

Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction.  Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving.  Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.  The most successful firms apply critical assessment of their needs and gaps at present and in the future, and deploy a risk-based approach to their quality system.