Client Alerts

Published 2023

The eSTAR and I - Encore #1

In Rodgers and Hammerstein’s Broadway hit The King and I, set in the 1860’s, the King was fascinated with science and innovation. He hired a schoolteacher, Anna, to be a governess to his children and educate them, to help modernize the country. In our adaptation, set in 2022, the King (FDA) implemented the voluntary eSTAR program to help modernize (and standardize) 510(k) and De Novo submissions. This submission format becomes mandatory starting October 1, 2023, for new 510(k) submissions in the kingdom. To help you gain experience and fully leverage this new submission format, we have created a four-part Client Series in tune with lyrics of the popular song from this musical “Getting to Know You”:

Encore: We hope you enjoyed the eSTAR series and are actively using the eSTAR templates to prepare your 510(k) or De Novo submissions, and now Pre-Subs (“PreSTARs”). As the eSTAR program continues to evolve, please check the Encores of this Client Alert series for updates on the eSTAR program.

Published 2023

Keep On The Sunny Side - The Sunshine Act

Implementing an appropriate Sunshine Act policy requires a fundamental understanding of the Act and its obligations. In this Client Alert we adderss three basic practices for Sunshine Act compliance:

I. Medical Device Companies Must Develop Policies and Procedures to “Keep on the Sunny Side” of Sunshine Act Compliance.

II. Medical Device Companies Must Establish an Appropriate Tone from the Top to “Keep on the Sunny Side” of Sunshine Act Compliance

III. Medical Device Companies Must Educate Employees About the Consequences of Misconduct to “Keep on the Sunny Side” of Sunshine Act Compliance

Published 2023

The eSTAR and I - Act IV

In Rodgers and Hammerstein’s Broadway hit The King and I, set in the 1860’s, the King was fascinated with science and innovation. He hired a schoolteacher, Anna, to be a governess to his children and educate them, to help modernize the country. In our adaptation, set in 2022, the King (FDA) implemented the voluntary eSTAR program to help modernize (and standardize) 510(k) and De Novo submissions. This submission format becomes mandatory starting October 1, 2023, for new 510(k) submissions in the kingdom. To help you gain experience and fully leverage this new submission format, we have created a four-part Client Series in tune with lyrics of the popular song from this musical “Getting to Know You”:

Act IV: Getting to Hope You Like Me – This final Act provides insights as to what to expect from the FDA review process of eSTAR submissions.

Published 2023

The eSTAR and I - Act III

In Rodgers and Hammerstein’s Broadway hit The King and I, set in the 1860’s, the King was fascinated with science and innovation. He hired a schoolteacher, Anna, to be a governess to his children and educate them, to help modernize the country. In our adaptation, set in 2022, the King (FDA) implemented the voluntary eSTAR program to help modernize (and standardize) 510(k) and De Novo submissions. This submission format becomes mandatory starting October 1, 2023, for new 510(k) submissions in the kingdom. To help you gain experience and fully leverage this new submission format, we have created a four-part Client Series in tune with lyrics of the popular song from this musical “Getting to Know You”:

Act III: Getting to Like You – In this riveting Act, we share best practices to optimize eSTAR submission presentation.

Published 2023

The eSTAR and I - Act II

In Rodgers and Hammerstein’s Broadway hit The King and I, set in the 1860’s, the King was fascinated with science and innovation. He hired a schoolteacher, Anna, to be a governess to his children and educate them, to help modernize the country. In our adaptation, set in 2022, the King (FDA) implemented the voluntary eSTAR program to help modernize (and standardize) 510(k) and De Novo submissions. This submission format becomes mandatory starting October 1, 2023, for new 510(k) submissions in the kingdom. To help you gain experience and fully leverage this new submission format, we have created a four-part Client Series in tune with lyrics of the popular song from this musical “Getting to Know You”:

Act II: Getting to Know All About You – This dynamic Act provides more detail and strategy for how to use the eSTAR submission format and complete the templates.

Published 2023

The eSTAR and I - Act I

In Rodgers and Hammerstein’s Broadway hit The King and I, set in the 1860’s, the King was fascinated with science and innovation. He hired a schoolteacher, Anna, to be a governess to his children and educate them, to help modernize the country. In our adaptation, set in 2022, the King (FDA) implemented the voluntary eSTAR program to help modernize (and standardize) 510(k) and De Novo submissions. This submission format becomes mandatory starting October 1, 2023, for new 510(k) submissions in the kingdom. To help you gain experience and fully leverage this new submission format, we have created a four-part Client Series in tune with lyrics of the popular song from this musical “Getting to Know You”:

Act I: Getting to Know You – This Act provided an overview of the FDA’s eSTAR program and templates.

Published 2023

2022 Industry Recap

In this Client Alert, DuVal & Associates, P.A. provides industry reflections from 2022 based on our collective experiences from the past year. From the frontlines at FDA to client strategy meetings, we share the industry and business insights we gained while advocating for device clearances and approvals, negotiating Pre-Submission meetings, responding to warning letters, and interacting with FDA and other regulatory bodies. Thank you to all of our Clients we served in 2022.

Published 2022

Q-Sub Program

2021 Retrospection Highlight

In January 2021, FDA updated its Q-Submission Program that provides for many types of interactions with FDA. For our clients, Pre-Submissions (Pre-Subs) and Submission Issue Requests (SIRs) have been the most popular and useful type of Q-Submissions. Pre-Subs can be very helpful to de-risk an IDE or commercialization (e.g., 510(k), De Novo, or PMA) submission.

Published 2022

Least Burdensome

2021 Retrospection Highlight

The year 2022 marks the 25th year since Congress first directed FDA to use a “least burdensome” (LB) approach when reviewing device applications with the enactment of FDAMA in 1997. The intent of the LB approach is to hold FDA accountable to require only the minimum information needed. Unfortunately, FDA’s implementation followed Lou Holtz’s quote “When all is said and done, more is said than done.”

Published 2022

Novel Device Programs

2021 Retrospection Highlight

FDA has two programs for novel medical devices: the Breakthrough Device Designation (BDD) and the Safer Technologies Program (STeP). The Breakthrough Device Designation (BDD) program has been gaining in popularity since its inception. In 2021, a little sister was born to the BDD program – the Safer Technologies Program (STeP). This program is very similar in concept to the BDD program but does not have the backing of regulation.

Published 2022

510(k) Program

2021 Retrospection Highlight

2021 was a mixed bag for the 510(k) program. The vast majority of products that come to the market are through the 510(k) path. As such, it remains critical that we evaluate how the FDA is doing with clearances. To understand FDA’s view of the 510(k) path, one has to understand the history of Dr. Shuren’s tenure with CDRH.

Published 2022

De Novo Program

2021 Retrospection Highlight

In October, FDA issued a final rule on the De Novo Classification Process. The new regulation is 21 CFR Part 860 and becomes effective on January 3, 2022 (90 days after publication of the rule). In association with this update, FDA released multiple guidance documents to assist with the preparation of these submissions.

Published 2022

Combination Products

2021 Retrospection Highlight

FDA’s regulation of drug, device and combination products has an extensive legislative, judicial and experiential history that would lead one to expect that the regulatory pathway for a given product type, especially one that has been in the U.S. market for decades, should be well-established.

Published 2022

Off-Label Communications & The New Intended Use Regulations

2021 Retrospection Highlight

After a nearly five-year delay, FDA’s new “intended use” rule, 21 CFR § 801.4, finally became effective on September 1, 2021. Under the new rule, FDA clarifies the types of evidence relevant to determining the intended use of a medical device under the Food, Drug & Cosmetic Act.

Published 2022

Digital Health & Multiple Device Function

2021 Retrospection Highlight

The digital health space continued to grow in 2021, and is becoming an integral part of healthcare during the COVID- 19 pandemic. Over the past two years people have become more accustomed to telehealth and taking an active role in their health, including using wearable technology to monitor health and wellbeing.

Published 2022

2021 Retrospections

In this Client Alert, DuVal & Associates, P.A. provides industry retrospections from 2021 and an outlook of our expectations for 2022. The retrospections are based on our collective experiences from 2021.

Published 2021

The Good, The Bad, Avoiding The Ugly

In this Client Alert we anaylze an interesting phenomenon experienced at the Medtech MVP Conference in Minneapolis on Tuesday, September 28, 2021 when two panels presented divergent views on the performance of CDRH. We ask: “How can that be?”

Published 2021

Do You Want To Build A Program?

Will the FDA STeP Program Live Happily Ever After Like Elsa? At first glance, Frozen has little relevance to the medical device industry. But Elsa and Anna’s contrasting characters serve as a useful analogy when comparing the Food & Drug Administration’s (“FDA”) Breakthrough Devices Program with its new, sister program, the “Safer Technologies Program” or “STeP” Program. While this is a cutesy analogy for our firm, given our past Client Alerts, Frozen is popular enough to have universal understanding.

Published 2017

When Do 510(k) Modifications Transform a Device?

Transformers® start out as a car or truck, but with a few gyrations they morph into a fighting machine capable of attacking enemies or defending friends. Surely, they do not look anything like they did before, but has their essential character changed, has their intended use? Do the changes significantly affect their safety or effectiveness?

Published 2016

Howard Root & Vascular Solutions Acquittal

This is a story of a CEO and a company in which the government brought a criminal case based upon the alleged off-label promotion of a 510(k) cleared medical device.

Published 2015

FDA Loses Another Off-Label Court Decision - Is Amarim Three Strikes and You’re Out?

Amarin and other cases like it challenge the conventional wisdom (is it acquiescence?) that FDA can regulate off-label speech to the extent it has.

Published 2014

David (Ivy Sports) Beats Goliath (FDA)

FDA again misjudged its strength and position and the little principled warrior, Ivy Sports Medicine, LLC, whose predecessor was ReGen Biologics. In this epic battle Ivy Sports is a small company and seemingly ill-equipped to do battle with the giant, FDA.

Published 2014

General vs. Specific Use Through The Eye Of A Needle

FDA is reinterpreting FDA’s view of “general versus specific intended use” so narrowly that FDA now considers almost every new indication for a 510(k) device to be a new intended use in contravention of the specific intent of the Congress

Published 2014

FDA Fails To Review Data In The "Stage-Gated" Review of a 510(k)

Is FDA not reviewing your data in a 510(k) submission? Have you ever received a Not Substantially Equivalent (NSE) letter from FDA stating your device does not meet of the definitional elements of “substantial equivalence?” Did FDA do this without even looking at your data when you data may have helped your device meet the SE definition?

Published 2013

Little Red Riding Hood and the Big Bad Wolf: Beware of De Novo

You remember the story; the Wolf disguises himself as Little Red Riding Hood, alters his voice and demeanor, draws Grandma in and then devours her. The beginning of that story serves as a metaphor for the way in which the de novo program looks like—a benign substitute for the 510(k) program. And when a company is drawn into a de novo review by the FDA, the company gets devoured.

Published 2012

510(k)s/IDEs: The New Normal?

In this CLIENT ALERT we offer you a four part series (contained in one document) covering our thoughts on the current 510(k) and pre-IDE programs. We provide some practical insights on what it is like to approach FDA today on a 510(k), whether you start with a pre-IDE meeting or you get into a clinical discussion after a 510(k) submission.

Published 2009

Lawful Pre-Approval And Pre-Clearance Communication

There are many pre-clearance/approval activities a medical device company can lawfully engage in prior to attaining their 510(k) clearance/approval of a medical device. This DuVal Client Alert provides insight into these activities.

510(k) - Dotting The I's And Crossing The T's

The 1st Client Alert in Our 510(k) Series

510(k) - Seven Quick Tips

The 2nd Client Alert in Our 510(k) Series

510(k) - Choosing The Proper Predicate Devices

The 3rd Client Alert in Our 510(k) Series

510(k) - Clearing Your Indications for Use

The 4th Client Alert in Our 510(k) Series

510(k) - Addressing Technological Characteristics in Your 510(k)

The 5th Client Alert in Our 510(k) Series

510(k) - When Does Your Device Raise Different Questions of Safety and Effectiveness?

The 6th Client Alert in Our 510(k) Series

510(k) - What is the quantum and quality of information needed for your 510(k)?

The 7th Client Alert in Our 510(k) Series

Pre-Submission #1
The Idea Behind It

The 1st Client Alert in Our Pre-Sub Series

Pre-Submission #2
The Technical And Strategic Aspects

The 2nd Client Alert in Our Pre-Sub Series

Pre-Submission #3
Issues We've Encountered

The 3rd Client Alert in Our Pre-Sub Series