The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about common 510(k) mistakes and how to avoid them. They also cover what has changed (if anything) in the past five years since Jon wrote the article, 7 Common Mistakes That Sink FDA 510(k) Clearance.

• Mistake #1 - Inconsistency with Documentation: The intended use statement often is inconsistently put into other sections of the 510(k). It’s important to understand the difference between indications for and intended use.
• Mistake #2 - Not Using Checklist: The FDA’s 510(k) submission guidance provides a Refuse to Accept (RTA) checklist. Help yourself and reviewers out. The FDA states what it is going to do and what it wants, so there should be no surprises.
• Mistake #3 - Not Providing All Expected Testing: The FDA rarely accepts promissory commitments to do sterilization, validation, or biocompatibility testing later. Also, you should include protocols, results, and reports to verify rigorousness of testing.
• Mistake #4 - Not Doing Real-time Shelf-life Studies: FDA wants evidence to back up claims of stated shelf life and wants a correlation between real-time and accelerated aging data. Shelf life is what happens to your product in the future.
• Mistake #5 - Underestimating Risk Management Requirements: Show list of requirements and provide the paper trail for your traceability. The FDA needs to conclude that your product is safe and substantially equivalent to a predicate.
• Mistake #6 - Not Demonstrating Equivalence with Predicates: You need to depict your device as novel and unique, but not so different that the FDA thinks your predicate is not a good example.
• Mistake #7 - Formatting Submission Incorrectly: Include page numbers and an eCopy. Also, the size of the file matters and needs to be named according to conventions.

“The intended use statement is a pretty important premise for any 510(k) submission because for all intents and purposes, that statement helps regulators and helps you determine how your product is ultimately going to be classified.” Jon Speer

“One of the most common reasons why they are rejected is because the high-level labeling when it is repeated is not repeated exactly the same way.” Mike Drues

“Intended use focuses on the device. Whereas, indications for use focuses on the patient.” Mike Drues

“The RTA checklist was intended to be a tool for the FDA reviewer, when submission received, for them to go through and make sure all the constituent parts and components and what is expected to be in that submission is included.” Jon Speer

“FDA reviewers see probably dozens, maybe hundreds of submissions in a finite period of time. Some are better than others. Well, make yours standout. Make yours easier to read.” Jon Speer

7 Common Mistakes That Sink FDA 510(k) Clearance

FDA - 510(k) Submission Process

7 FDA Pathways to Bring Your Medical Device to Market

Center for Devices and Radiological Health (CDRH)

ISO 14971

Mike Drues on LinkedIn

Vascular Sciences

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru

How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when researching clinical evidence? 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Keith and Kevin Kallmes of Nested Knowledge. Following in the footsteps of their father who was a medical device inventor, the two brothers designed and developed a balloon catheter that was acquired by a major strategic. 

• Keith and Kevin focus on clinical, regulatory, and publication consulting in the data management/data analysis services industry.
• Like other entrepreneurs, Keith and Kevin understand the importance of central clinical outcomes data in every stage of the medical device development process for a product rooted in an unmet clinical need.
• Engineers tend to focus on the immediate task at hand. Entrepreneurs have to consider why startups succeed or fail. Rather than fixating on money, the biggest reason devices fail is a lack of product market fit.
• Companies should look at the science before the development. Examine clinical evidence, decision-making, prototyping, and design controls.
• Customer Discovery: Read literature and talk to clinicians about needs. They are on the frontlines of patient care and research-capable.
• To find scientific evidence and outcomes, search for different articles and filter/screen the articles to know when you have enough relevant information.
• Calculate risk, know timelines, perform tests, and document design history accurately or start the design process over and learn an expensive lesson.
• Which evidence is leading to which decisions? Share and manage evidence to make sure it is usable and effective. 

“You really realize how central clinical outcomes data are to every stage of the medical device development process.” Keith Kallmes

“It’s looking at clinical evidence and convincing end users and purchasers that your device is worth the cost.” Keith Kallmes

“You should be making good decisions and good decisions should pre-exist everything in the development landscape. Design controls should come only after you’ve basically validated your need and you’ve prototyped enough that you know that you should continue.” Kevin Kallmes

“Lack of product market fit - that’s why devices fail. They’re not addressing an unmet need in the marketplace.” Keith Kallmes

“Start your design controls at concept.” Kevin Kallmes

Keith Kallmes on LinkedIn

Kevin Kallmes on LinkedIn

Etienne Nichols on LinkedIn

Nested Knowledge

PubMed

FDA - Medical Device Overview

ISO - Medical Device Testing

GG Academy

MedTech Nation

Greenlight Guru

What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech. Duane has experience in go-to-market strategy, including regulatory and reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design and execution. He has developed a comprehensive understanding of what early-stage startups need to do to be successful.

With all of the complexities of running a medtech company and taking a product to the market, Duane has seen a huge variation in how startups develop strategies and milestones. In this episode, we discuss how early decisions impact other aspects in the future and how companies can create a blueprint to build and grow long-term.

• Fundraising: Figure out who you want to raise capital from, what should be in your pitch deck, and what questions will investors ask about problems/solutions.
• When trying to raise money, startups need to know that there are three types of investors—good, neutral, and bad. Sometimes, bad investors are hard to spot.
• When considering acquiring a company, some of the top things strategics look at is how you capture more clients, build your team, incorporate a quality management system (QMS), and handle regulatory challenges.
• If you are selling products to a hospital system, you will need to check three things—physician/clinician (especially nurses) ownership, patient improvement, and economic benefit.
• Build, develop, and invest in your team by finding people who complement your weaknesses. Don’t be afraid to fractionalize. One of the most important thing you can do for your company is to find advisors, partners, and mentors with large professional networks.
• When people are raising money, unless you are raising from a high net worth individual or angel group, be strategic with who you want to raise money. Venture Capitalists have a responsibility to spend (invest) their money just like you have a responsibility to raise it.
• Clients need to understand that regulatory fits into their business, clinical, reimbursement, and commercialization strategies—all those things work together and overlap, so make sure to ask the right questions to the right expert.

“The #1 thing we try to tell all of our startups when they’re going out to raise money is there’s three types of investors. There’s good, neutral, and bad. You really want to avoid bad.”

“For those first few investors, you want to find a good investor. Someone who’s going to bring something else to the table. Fill a knowledge or network gap that you don’t have. Understand what your mission is for the company and how they are going to support it.”

“We talk to a lot of investors and a lot of entrepreneurs, and the one thing we’ve learned is that there is more than one way to raise money. However, there are patterns.”

 “Regulatory fits into your business strategy, fits into your clinical strategy, fits into your commercialization strategy—all those things work together and overlap.”

Duane Mancini on LinkedIn

Project Medtech

Project Medtech Podcast

Etienne Nichols on LinkedIn

FDA - Overview of Device Regulation

FDA - 510(k) Clearances

FDA - Premarket Approval (PMA)

Build by Tony Fadell

GG Academy

MedTech Nation

Greenlight Guru

The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? 

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practices.

Jeff has 25 years of experience in the medical device industry, specializes in getting new devices to market, and scaling your commercialization. He has extensive knowledge and understanding of ISO 11607-1 & -2, Packaging for Terminally Sterilized Medical Devices.

• Sterilization validations/revalidations take a lot of money ($40,000-80,000) and a long time (16-20 weeks) to complete.
• Don’t underestimate labeling - 40% of FDA recalls are due to labeling. Make sure your CM has good labeling controls.
• Over a third of all package validations fail the lab test for transit. The biggest reason why companies fail packaging validation is not understanding the various shipping modes and their related testing.
• ISO’s 11607 standard has two parts: Part 1 is about designing the package; Part 2 is validating the package. Also, there is a guidance document due to the complexity of the packaging process.
• The criteria for filing a 510(k) and steps related to packaging include validating that the seals are good from a sterile barrier standpoint and the product is good and has not changed over time because of transit testing or aging.
• From a design standpoint, document how the package has been designed and meets customers’ needs. Recently, the FDA added user testing to the standard for sterile transfer.
• Feasibility testing of prototypes and samples of vibration, drops, and humidity should be conducted to prevent potential problems. Ask engineers about product changes and the risks for redesign of packaging to know if the package will fail or pass.

“The FDA looks at a standard called ISO 11607. That is the Bible for medical device packaging validation. There’s two parts to it, Part 1 and Part 2. Part 1 is all about designing the package and Part 2 is about validating the package.” 

“Over a third of all package validations failed at the lab for transit. It’s staggering.” 

“Less so do we see damage to the product itself. So, I’d say, 8 out of 10 times on these failures, it’s the product and the seal failing, not the product breaking.” 

“One of the biggest problems we see is, (the FDA) they don’t do any validation. They say, ‘We’re going to do it later.’ That’s obviously a problem. You can’t market the product if the package hasn’t been validated. That’s why the FDA gives you a break on that.”

“The bottom line is you’re trying to maintain the product without getting damaged and without the sterile barriers getting damaged. That is the end goal.”

Jeff Barrett on LinkedIn

J-Pac Medical

Etienne Nichols on LinkedIn

ISO 11607-1

ISO 11607-2

ISO 13485

ASTM International

FDA - 510(k) Clearances

GG Academy

MedTech Nation

Greenlight Guru

What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.

• When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.
• If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.
• It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.
• Competition: When most medical devices are being developed, there is intent. Either it’s a completely new idea or existing product that another manufacturer offers that you want to build or improve upon.
• Prop 65 and new European regulations strive to keep out carcinogens, mutagens, reproductive toxins, and other compounds that at certain thresholds may be of concern and should not be included in devices or labeling is required.
• When it comes to quality, ISO standards and FDA regulations are in the best interest of the patient but may be a costly burden for the manufacturers. It takes units of a medical device to complete evaluations for biocompatibility testing.
• It takes days, months, or requires extensions for some companies to do remedial work and meet expectations when responding to a deficiency.
• Implement quality from the beginning with a quality management system (QMS) to understand expectations of standards, practices, and regulations. 

“In a fair number of instances, there are cases where the FDA issues what we call a deficiency. It’s otherwise known as a request for additional information. But generally, what it is, is they have a question or an issue with some part of the submission.”

“Be proactive, not reactive because then a little bit of time upfront will save you a lot of time on the backend.”

“A lot of devices, when they are being developed, you’re doing it with intent in mind. Either it’s a completely novel, new idea or you saw a product and you said there’s a greater market than a particular other manufacturer offers, we want to jump into it or we want to improve it.”

“Let’s try to keep out anything of potential concern that we can at any concentration.”

Chris Parker on LinkedIn

Labcorp

Etienne Nichols on LinkedIn

FDA - Overview of Device Regulation

FDA - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

ISO 10993-1:2018 - Biological evaluation of medical devices

Proposition 65

European Union Medical Device Regulation (EU MDR)

Medical Design and Manufacturing Event (MD&M West)

GG Academy

MedTech Nation

Greenlight Guru

Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get 483 observations year after year.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about whether your medical device company’s CAPA process needs a CAPA. Why are medical devices companies continuing to struggle with CAPAs?

• Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or FDA. People tend to report every little event as a CAPA or report nothing at all. 
• The five most common reasons why the FDA issued 483 observations and warning letters over the last 5 years were CAPAs, customer complaints, purchasing controls, medical device reporting, and process validation.
• If CAPA is the #1 reason why companies are getting 483 observations and warning letters, it may be due to an ineffective quality management system (QMS).
• Things happen every day during the course of running a business. Processes and routines may not go routinely. When something happens unexpectedly, will it happen again? What are you changing to ensure it does not happen again?
• CAPAs continue be the #1 reason because people do not have a common sense understanding of the quality system regulation. They focus on the words, but do not try to understand the meaning.
• CAPAs often generate negative connotations—the process requires extra work and more resources, not in the budget, and time pressure. However, people should view CAPA’s as an opportunity to improve a product and prevent problems in the future. 
• People do not follow procedures because sometimes they don’t even know that procedures exist, or those procedures are not updated/revised after events.

“A CAPA is an opportunity to really do a deep dive investigation to determine, is there a systemic issue that is influencing that process that you are following?” Jon Speer

 “People don’t focus on the common sensical understanding.” Mike Drues

 “Unless regulation makes sense, I don’t care what the regulation is, unless it makes sense, it is not good regulation.” Mike Drues

 “Part of going through the CAPA procedure is to identify the root cause of the problem.” Mike Drues

 “Only 3-5% of adverse events of medical devices are actually reported to the manufacturer or to the FDA.” Mike Drues

FDA - Corrective and Preventive Actions (CAPA)

FDA - Form 483 Observations and Warning Letters

FDA - Medical Device Overview

International Medical Device Regulators Forum (IMDRF)

ISO 13485 CAPA

21 CFR Part 820

Mike Drues on LinkedIn

Greenlight Guru Academy

Greenlight Guru Community

MedTech Nation

Greenlight Guru MedTech Lifecycle Excellence

What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the four quadrants of UDI that companies need to be aware of? Don’t underestimate your time to comply because it always takes longer than expected.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Gary Saner, Senior Manager of Information Solutions for Life Sciences at Reed Tech, about UDI and the current state of global implementation.

Gary has been helping companies achieve UDI compliance on a global scale for years.  He is considered to be a thought leader and recognized authority on medical device UDI compliance.

• As the U.S. FDA Class I UDI deadline approaches, companies should refer to the FDA’s final guidance, which describes the compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.
• Delays seem to be a part of the history of UDI. Manufacturers face challenges and pitfalls from UDI being rolled out easily. There are a number of issues with the brand new requirement in the United States.
• The four quadrants of UDI are identifying a product, reprocessed/reused products, reporting attributes, and documenting standard operating procedures (SOPs) in a quality management system (QMS).
• The EU has a complicated UDI implementation schedule, as well. Delays have been announced, but the impact was due to the European Commission completely revamping the regulatory platform. 
• In Europe, UDI becomes one of the many things that a manufacturer has to learn, be educated on, and respond to. There’s no grandfathering of products, notified bodies, and patients. Portfolios are re-evaluated to meet new regulations.
• With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some health authorities around the world base their policies on one or the other. However, good global harmonization is not in place.

“This is a challenge in that this particular dataset has never really been assembled before. So, there’s no precedent for this.”

“The other issue is sometimes you find the data and it’s not accurate or it hasn’t been touched for a while. It’s not current. It’s obsolete. There’s issues with formatting. Sometimes, the formatting of that data that’s held for internal processes is not the format that actually gets submitted to the FDA.”

“There’s a little bit of a nuance about making sure the acknowledgements that come back from CDRH, there’s three acknowledgements, and making sure that they’re all complete for every single record.”

“UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to and there was no grandfathering of products.”

“With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some of the other health authorities around the world will kind of base their policies on one or the other - US or EU.” 

Information Solutions - Life Sciences at Reed Tech

Gary Saner on LinkedIn

The Ultimate Guide to UDI

FDA - Unique Device Identification (UDI) System

FDA - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

Center for Devices and Radiological Health (CDRH)

European Union Medical Device Regulation (EU MDR)

EU In Vitro Diagnostics Regulation (IVDR)

EUDAMED

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru MedTech Lifecycle Excellence

Greenlight Guru YouTube Channel

Etienne Nichols on LinkedIn

How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access?   

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Joe Mullings, chairman and CEO of the Mullings Group companies, about finding true quality talent and celebrating excellence and hyper-competency to make lives better. 

Joe’s search firm is responsible for more than 8,000 successful searches in the medtech/healthtech/life sciences industry. DragonFly Stories produces attention and awareness campaigns for companies globally through TrueFuture. TMG360 Media utilizes the power of media and outreach in medtech/healthtech to move businesses and health forward.

• Quality of Outcome vs. Opportunity: Organizations are realizing that it’s much more expensive to lose and replace a good player rather than retain a good player. The quality and output of an employee’s work matters.
• Networking should occur when you don’t need it. Be clever, bring value, give and not take, and create a brand around yourself.
• The workforce and global economy has changed because of the worldwide pandemic. Things are starting to settle down, and it’s time to reset, re-define, and re-evaluate employees’ responses to work and fulfillment.
• WFX: Where are employees willing and wanting to work—from home, anywhere, or in the office—and how does that affect organizations’ willingness when it comes to compensation, flexibility, and the networking process to retain talent?
• Two-way communication between workers and employers needs to be created to find balance and reduce friction for healthy relationships. The catalyst for people switching or leaving their jobs is to make more money. However, top performers want to move forward in their career from their own developmental perspective and grow their skills.
• The non-negotiables of working in the office or not depends on your degree and years of experience. If you’re new, it’s best to work in the office to learn and mimic others. Then, it depends on your job function.
• The best way to represent yourself in the marketplace is based on your behaviors and how you package yourself when appearing in front of others.

“We are the #1 search firm in the world, first of all, in the medical device/healthtech industry with more than 8,000 successful placements over three decades.”

“Compensation, right now, is also being driven by supply and demand.”

“You’ve got better career choices now, and you’ve also got the ability to live, potentially, a better life.”

“Let’s keep a better balance of power in the workforce instead of it being futile in nature where the companies call all the shots.”

“The digital scales your idiocy as well as your competency equally.”

Joe Mullings on LinkedIn

The Mullings Group - TMG Search

TMG360 Media

DragonFly Stories

TrueFuture

Out of the Crisis

Etienne Nichols on LinkedIn

Greenlight Guru Academy

Greenlight Guru Community

MedTech Nation

Greenlight Guru

What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Rahul Kallampunathil, Vice President of Arbour Group’s Digital Compliance practice, about digitizing your SaMD testing.

Rahul builds teams that help companies proactively manage compliance risks toward a true digital enterprise. He is an innovative thinker with more than 18 years of experience in risk management, compliance, and internal controls focused on information technology and data. 

• Rahul defines SaMD as software used to perform a medical purpose without being part of a hardware medical device. SaMD is capable of running on any general purpose platform, such as your Android or iOS mobile phone.
• SaMD is different from software in a medical device (SiMD). SaMD is independent from hardware; SiMD is embedded in a physical medical device.
• Also, there’s differences between SaMD and medical device data systems (MDDS). MDDS only transfers, stores, or displays medical device data, but it does not have an algorithm or business rule to help make medical decisions.
• IEC 62304 impacts SaMD organizations and how they approach the risk of their solution. All SaMDs are not equal, and it’s important to understand the level of risk in every SaMD.
• Companies should prepare for SaMD testing with a clinical evaluation to demonstrate a valid clinical association between SaMD’s output and targeted clinical condition.
• Before thinking about designing and developing a product, a quality management system (QMS) should be established. Software companies need to adopt and modify their QMS to serve their product and its users, while fulfilling FDA requirements.
• Rahul discusses the pros and cons of manual versus automated/electronic  documentation and testing, including risk management for patient safety.
• Best practices for SaMD testing are using agile and devops methodologies. Potential pitfalls are not testing continuously, even after the product is on the market. 

“Software as a medical device - it is software that is intended to be used for a medical purpose, and it performs that purpose without being part of a hardware medical device.”

“There is no physical device, in this case, that you can touch and feel. It’s purely software.”

“The nature of software - it’s something that you cannot touch or see. It’s all code. From a testing perspective, especially, there’s a lot of things that you need to pay attention to.”

 “The quality management system or quality management process, that has to be established even before you think about the product, even before you design the product.”

Rahul Kallampunathil on LinkedIn

Etienne Nichols on LinkedIn

Arbour Group LLC

FDA - SaMD

FDA - Medical Device Data Systems (MDDS)

FDA - Cybersecurity

IEC 62304

International Medical Device Regulators Forum (IMDRF)

Greenlight Guru YouTube Channel

Greenlight Guru Community

Greenlight Guru Academy

MedTech Nation

Greenlight Guru

After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the FDA’s Refusal to Accept (RTA) policy and guidance. 

• After the FDA receives a 510(k), De Novo, Pre-Market Approval (PMA), or any other submission, the 2-step process is to conduct an administrative and then a substantive/scientific review.
• If a submission is rejected on the administrative review, it is completely the company’s fault, not the FDA’s. If the substantive review is rejected, however, there’s room for negotiation with the FDA.
• Most of the FDA’s acceptance checklists have been available for more than a decade, but companies submissions are still commonly rejected on administrative review.
• Electronic tools and software platforms, such as eSTAR, are supposed to help and facilitate the preparation process of submissions. The problem is, this is contingent on what information is entered.
• Potential hangups for companies using tools like eSTAR for the submission process are that they do not evaluate the quality of the content entered. That said, they do require a Table of Contents and the use of most current forms.
• Never leave any sections of your submission blank. At the very least, enter Not Applicable (N/A) and explain why - or risk the FDA rejecting the submission. It’s a company’s responsibility to make sure the FDA understands their device.
• The draft guidance documents have been published for a reason - don’t ignore them and risk a rejection for what could easily have been avoided. 

“If a submission gets rejected on an administrative review, that is 100% the company’s fault, it is not FDA’s fault.” Mike Drues

“Approximately 60% of 510(k)s are rejected on RTA part of the administrative review.” Mike Drues

“An eTool should help facilitate the process. However, caveat—it still is contingent on humans entering information.” Jon Speer

“I would like the FDA to be just as careful with the claims that they put on their own website as they are when they are evaluating claims on a device coming in for a submission.” Mike Drues

“One of the most common reasons why submissions are rejected is because a particular section is left out. Put yourself in the shoes of the reviewer. They have no idea why you are leaving out that section.” Mike Drues

How To Avoid Having Your FDA Submission Rejected (And What To Do If It Is)

Guidance: Refuse to Accept (RTA) Policy for 510(k)s

Guidance: Acceptance Review for De Novo Classification Requests

Guidance: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

Acceptance Checklists for 510(k)s

Medical Device User Fee Amendments (MDUFA)

FDA - Voluntary eSTAR Program

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Mike Drues on LinkedIn

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru Academy

Greenlight Guru Community

Greenlight Guru