The Digital World, Medical Devices, and FDA.

The guidance documents listed here are FDA guidances with Digital Health content and are intended to help industry and FDA staff understand FDA's regulation of digital health products.

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in the guidance documents below.

If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email

List of FDA Guidance Documents with Digital Health Content


OPPORTUNITY: Medical Device Design Engineer [012090]

The FDA Group is recruiting

We have a client in the Seattle-metro area who is looking for a medical device mechanical design engineer with the following qualifications

More than 5 years professional experience.

Education: Bachelor's Degree in Mechanical Engineering over equivalent.

Performs engineering duties; develops, designs, and tests mechanical devices. Writes technical reports, handbooks, and bulletins for use by staff or customers. Researches designs and makes recommendations based on appearance, safety, budget, and function.

RCA and Quality improvement activities a plus.
Works well in team environment but can also work independently.
Creo 3.0 experience preferred.
Knowledge of working with outside suppliers both domestic and foreign.

Te position is to start as soon as possible and last 18 weeks with the possibility of extension.  This is a highly competitive opportunity and rate is a very important factor. 

If you can help with this engagement please contact Brie Stoianoff,, +1 5037509178 with a brief 1-2 paragraph statement of your expertise as it relates to this matter as well as the rate you would be willing to accept.  If you know of someone else who may be a good fit, please share that with me as well.  Please keep in mind that if you respond to this opportunity and want to get an update, simply click on this link and enter the project number located in the subject line. 

Being an Expert Witness

I am very fortunate that my over 40 years of FDA Medical Device experience has allowed me to serve as an expert witness in cases involving FDA regulation of medical devices.   The experience is one that is quite unique and does present significant challenges.

I want to thank The Expert Institute for the guidance they provide to assist expert witnesses.  This is from a recent article by The Expert Institute.  

Top 15 Tips for Testifying as an Expert Witness

1.) Draft a Comprehensive Retainer Agreement
The foundation of any solid attorney-expert witness relationship is a comprehensive retainer agreement. The retainer agreement should specify all pertinent terms and obligations of both the attorney and expert. The services to be performed, the general preparation required, and the expert’s fees should all be clearly stated in writing. If the expectations of both parties are established, they are less likely to have misunderstandings down the road.

2.) Discuss Any Potential Disqualification Issues Beforehand
Before preparation for trial commences, it is important for the expert to disclose any potential disqualification issues. An expert’s testimony may be disqualified for substantive reasons, for example, if the science behind the expert opinion is considered novel and untested. Other disqualifications may occur because of conflicts of interest, such as the expert having been previously employed by or hired as an expert for the opposing party. Because the disqualification of an expert can be detrimental to a case, it is important to discuss these issues as early on as possible.

3.) Find Out the Specifics of What You Are Testifying About
While a retainer agreement should state the general subject matter at issue in the case, experts should always verify the exact nature of the testimony that the attorney is seeking. Particularly in regard to highly complex scientific matters, a greater degree of specification may be necessary so that the experts may tailor their testimony accordingly. In addition, any experiments or testing that needs to be conducted should be stated, so that the expert may be fully prepared.

4.) Update Your Curriculum Vitae
While experts will have the opportunity to establish their credentials in court, a concise, up-to-date curriculum vitae that showcases their expertise in the subject matter at issue is vital. A curriculum vitae that strongly conveys the witness’ qualifications may even result in the uncontested declaration of the witness as an expert prior to trial, saving both the time and effort of conducting a voir dire.

5.) Obtain and Review Any and All Necessary Materials
In order to reach a fully formed opinion, all necessary file materials must be obtained and reviewed in a timely manner. Any materials that an expert will need should be provided by the attorney as soon as practically possible. In addition, any rules and regulations governing the dissemination of the materials should be disclosed, such as whether they are under a protective order by the court.

6.) Find Out if a Written Report is Needed
In federal courts (and certain state jurisdictions), expert witnesses are required to provide a written report pursuant to Rule 26 of the Federal Rules of Civil Procedure. Under Rule 26, expert witnesses must disclose a report previewing the expert’s proposed testimony to the opposing party. The report must contain “all opinions the witness will express and the basis and reasons for them.” As such, experts should be aware of this requirement well before the due date of the report.

 7.) Be Careful with Written Communications
If the above rule is applicable, experts must be mindful of all written communications. In addition to laying out the basis of the expert’s opinion, Rule 26(a)(2)(B) of the Federal Rules of Civil Procedure also mandates disclosure of facts or data considered by the witness, any exhibits the expert intends to use, the witness’ qualifications, a list of other cases in which the witness testified, and a statement regarding the expert’s compensation for testifying. Therefore, any documents created by the expert may be discoverable.

8.) Inquire as to Other Expert Witnesses
Knowing whether other experts are testifying can help narrow down the scope of the expert’s own testimony. If other experts will be handling different aspects of the subject matter, then each expert is free to focus on one specific area. Particularly in regard to highly complex or technical issues, it may be helpful that each expert concentrates on its own sub-topic, opposed to one expert flooding the jury with testimony that may overlap with the subsequent testimony of another expert.

9.) Outline a Case Theory
The general purpose of the expert’s testimony is to clearly explain a particular issue of fact. Understanding the case theory, and how the expert’s testimony fits within that narrative, ensures that the expert will remain on track. If the one basic purpose of the testimony remains in the forefront of the expert’s mind, it is easier to craft testimony that concisely addresses the issues.

10.) Prepare, Prepare, Prepare!
Whether an expert is experienced in testifying before a jury or not, it can still be unnerving. Also, all attorneys – including opposing counsel – have their own style, which an expert may need some time to get used to. Once the general outline of the direct examination is finished, the attorney and expert should dedicate time to reviewing the material. This can prevent mistakes from occurring inside the courtroom.

11.) Practice Your Demeanor and Non-verbal Cues
In the same regard, it is vital to practice how one comes across to a jury. The actual testimony presented is only half the battle. An expert’s demeanor, posture, phrasing, tone, and other verbal and non-verbal cues are all taken into account when a jury is determining credibility. Overall, an expert should appear experienced but also likeable and trustworthy in the eyes of a jury.

12.) Be Prepared for a Daubert Challenge
A Daubert motion, named after Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court case upon which the standard for expert testimony is based, seeks to exclude the testimony of an expert witness that is not relevant or reliable. When deciding whether to admit the testimony, a judge will consider the factors outlined in Daubert. While the factors enumerated by the Daubert Court are non-exhaustive, all experts should familiarize themselves with the case, if testifying in a jurisdiction that follows that standard. A Daubert challenge is typically made before trial has commenced, and one of the first ways in which opposing counsel may disqualify the expert.

13.) Be Mindful of the Voir Dire Process
A Daubert challenge is not the only time that an expert may be disqualified. The voir dire process, notably different from a Daubert challenge, centers on whether the expert is qualified to testify as to the subject matter at hand. At the beginning of the direct examination, the expert testifies to his educational background, work experience, training, and other qualifications. After this initial inquiry, opposing counsel then gets the opportunity to question the expert. Once the court rules that the witness is qualified to testify as an expert, the direct examination can continue. Opposing counsel may be able to disqualify the expert if the expert’s qualifications are weak, or if a conflict of interest exists. Therefore, an expert’s qualifications should be clearly established at the onset of the direct examination, and any conflicts of interest should be discovered well before trial.

14.) A Direct Examination that Flows
While there are many ways to conduct a successful direct examination, the main goal is to ensure that the jury better understands the facts at issue. Therefore, an expert’s testimony on direct should not just be a rote repetition of scientific terminology. The expert should use lay terms whenever possible, and explain the material by breaking it down into sub-topics or using analogies. Presentation is also important – speaking in a slow and concise manner is much easier to understand.

15.) Surviving Cross Examination – Always Remain Calm
Cross examinations have a reputation for being combative. However, that does not mean that the expert should fight or struggle with opposing counsel. Sometimes, it is not what is said but how it is said that matters. Although opposing counsel may attack the expert’s direct testimony, a calm response will always trump an aggressive one. If an expert remains in control of his testimony, it is likely he may be able to sidestep or pivot a question and still maintain credibility. After all, it is opposing counsel’s job to discredit the expert in any way possible, but how the expert handles the situation can make all the difference.



Management Review for FDA ????



Those of you in the medical device industry are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820.  

The specific regulation is Part 820.20 (c) which states “Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.”

So, we perform Management Reviews because FDA regulations require it? (Hence the question mark after the title of this article.) In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this post, we will review how to perform effective management reviews, that will assist in the effective management of the company.

In the mid 90’s I was selected to be the Vice President of Regulatory Affairs and Quality Assurance for a major manufacturer of cardiovascular devices. The Management Review QSR requirement was relatively new, and I took on the responsibility of the Management Representative (as defined in the QSR) and established a Management Review procedure. I first met with the CEO and explained to him that the he would chair the Management Review meetings, and I wanted to make sure he received the information he considered valuable. He remarked that he would see the value of the effort if it allowed him to better manage the company. I proceeded to work with his staff to establish measurable quality indicators for each of their functions. Once that was accomplished, I took on the responsibility of collating the indicators and preparing presentation in graphical format.

We began having quarterly management reviews, per the approved procedure, and documented. The number of quality indicators was kept to less than 20, and the meetings served the purpose of identifying potential quality issues early and directing follow up.

At the end of my first year as the VP or RA/QA at my annual performance evaluation, I received the greatest compliment of any review I had experienced. My boss, the CEO said to me “Larry I see you more than just the VP or RA/QA, I see you as a business partner. The reviews you set up have made me a better leader, and I thank you for that.”  I certainly got clear picture of the value of the management reviews, but also accomplished something that that I think all VP’s of RA/QA should strive for, specifically to be seen as a member of the business team, and a valuable contributor to the success the business.

This brevity of this post does not allow for a detailed explanation of how to set up and accomplish effective management reviews. It is important for your company to understand FDA expectations for management review, and I stand ready to assist you establishing or fine tuning your management reviews, and providing clear value to your company.

Contact me at  or 314-499-5148

Why use external quality auditors?

We know that FDA's Quality System Regulation requires registered device firms to have regular internal quality audits.  Let's see what the regulation says.

"Sec. 820.22 Quality audit.
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented."

I have highlighted the section regarding how FDA describes the individuals who perform the audits.  Most mid to large companies attempt to meet this requirement by hiring one or more internal auditors and assigning them various systems to audit, so that over a year all major quality systems have been audited.  But this is not what the regulation requires.  Their is no requirement to hire internal auditors.  As a former VP or RA/QA at several large companies I now how much it costs to employ just one internal auditor.  Lets assume the annual salary of the auditor is $60,000, add the that the normal 30% overhead and you have a annual cost of $80,000 for one internal quality auditor.

Are you getting your moneys' worth?  Lets assume the internal auditor has 5 years of auditing experience and training in Part 820.   Using that knowledge they can know what procedures are necessary and determine if employees are following the procedures.  Audit observation are typically reference to not following a procedures.   You get all of this for $80,000 per year.

Now let look at using a well qualified outside quality auditor.  Typically this person will have 20+ years of experience (In my case 40+ years).  That experience will come from several employers and allow the auditor to dig deeper.  A bonus would be for the auditor to also have experience with FDA, thus very familiar with FDA expectations and procedures.  For deep audits of major systems the outside auditor would require two weeks. But more importantly the outside auditor will not be limited to observing if procedures are being followed, the outside auditor will comment on deficient procedures, which is beyond the scope of almost all internal quality auditors.

The typical two week outside audit would cost the firm $35,000.    Two of these two week audits would then be a $70,000 annual cost, but more importantly you will receive an expert opinion your FDA compliance.  The numbers speak for themselves, the company can save money and have a higher level of auditing coverage, and greater possibility of FDA compliance, by using outside quality auditors rather than employing internal quality auditors.

Give us a call at 314-499-5148, or email   We can talk more about this.