The 510(k) Review Clock and How to Optimize Your Clearance Timeline

When thinking about FDA’s 510(k) review clock, there are several nuances that device developers should be aware of, which may impact time to clearance. Congress has given FDA 90 calendar days to review a 510(k), however, the average time to decision in 2016 was 141 days, which is a significantly longer timeline and indicates that 510(k) reviews are often not as simple as you’d hope. Waiting for FDA’s decision will be much easier if you have informed and accurate expectations, and know that you did everything in your power to gain clearance as quickly as possible.  A simplified timeline of communication during the 510(k) review is provided below. (Note: Days are in Calendar Days.)

Timeline of Communication During 510(k) Review

Screen Shot 2019-02-17 at 3.03.00 PM.png

Step 1: FDA 510(k) Submission Receipt

The first hurdle is having the FDA acknowledge receipt of your 510(k) submission.  FDA will send a formal Acknowledgement Letter or a Hold Letter if you haven’t properly paid the User Fee or submitted in an appropriate format. While technically a complete paper copy is still required according to the regulations, we recommend submitting a paper copy of just the Cover Sheet and the Cover Letter. You will save yourself some time and headache (and some trees) and won’t run the risk of forgetting a section or submitting pages out of order. Once the Acknowledgement Letter is sent to the applicant, FDA starts the Refuse to Accept (RTA) process.

Step 2: Refuse to Accept (RTA)

FDA staff will assess your submission using their Refuse to Accept checklist, which you can find here, to ensure that it contains all of the necessary information to conduct a full review for substantial equivalence. FDA will notify you within 15 calendar days of receipt of the submission whether it has been accepted. This communication will identify the reviewer assigned to your submission and will provide a decision regarding the acceptance/rejection of the submission based on the objective review criteria outlined in the RTA checklist.

Step 3: Substantive Review

Once your submission has been accepted for review, it enters the Substantive Review period, when the FDA review team evaluates the information provided in your submission for demonstration of substantial equivalence. Within 60 calendar days of receipt of the submission, FDA will provide you with a Substantive Interaction. FDA will either let you know that the submission review will continue interactively, signaling that FDA believes the issues in the submission are minor and can be resolved within the remaining 30 days, or FDA will send you a list of deficiencies putting the submission clock on hold with an Additional Information letter.

Step 3(a): Interactive Review

A Substantive Interaction could be a notification that the remainder of the review period can be conducted interactively, with minimal questions and clarifications. The review clock will continue to run, and you should be given your MDUFA decision within the 90 days from when your submission was received.

Step 3(b): Additional Information

Alternatively, if an Additional Information letter is issued, FDA’s 90-day review clock is put on hold, and the applicant then has 180 days to respond to the deficiencies in the letter. In 2018, 63% of 510(k)s received an Additional Information request. It is the large number of submissions that add time from the 180-day applicant review clock which pushes average review times out. Once the applicant submits their response to the Additional Information Letter deficiencies, FDA’s 90-day clock begins again, which would typically have another 30 days left on it.

Step 4: MDUFA Decision

At the end of the review clock, FDA will issue their MDUFA decision (Substantially Equivalent [SE] or Not Substantially Equivalent [NSE]).  In 2016, 83% of submissions were determined to be Substantially Equivalent, with an average time to decision of 141 days.

Each year, FDA releases performance goals that they set, and their recently released MDUFA Performance Goals and Procedures for Fiscal Years 2018 through 2020 includes the following goals for 510(k) review times:

Total Time to Decision for 510(k) Submissions Received

Screen Shot 2019-02-17 at 3.08.07 PM.png


FDA has also identified process improvements that they intend to implement in order to reach these goals. Some of these improvements include increased staff training, development of additional guidance documents, and enhanced use of consensus standards, but perhaps the most important is a commitment to increase applicants’ awareness and utilization of the Refuse to Accept process.

According to an independent assessment of FDA’s Device Review Process Management conducted by Booz Allen, submissions that did not pass the Refuse to Accept review were associated with longer review times. Additionally, the most common reasons for rejection were Administrative in nature, easily avoidable mistakes that can be fixed by increasing applicants’ knowledge of the required administrative elements of a 510(k) and their use of the RTA checklist.

As FDA is taking steps internally to reduce the time to decision (SE or NSE), there are steps you as the device manufacturer or developer can take to shorten the review period that can be impactful and ensure swift clearance for your device.

  1. This goes without saying but familiarize yourself with the RTA checklist now (linked above). Refer to it throughout your submission assembly process, and identify any potential missing elements and course correct as soon as possible. You should also complete the RTA checklist yourself and include it with your final submission to ensure that it will be accepted for review. In the RTA checklist, cite the specific page that contains the requirement and help the FDA reviewer find the information.

  2. Utilize the pre-submission process. Pre-submission meetings are free, and while they take some time to schedule (60-75 days from when you submit the request), they can be extremely valuable. They give you the opportunity to have early and open dialogue with FDA about your product and your development, and get feedback on your intended use and predicate device. For example, you can discuss the testing required for your submission, so that you conduct the testing in full to include in the submission, rather than missing something that will end up resulting in an Additional Information deficiency.

  3. Explore alternative pathways that may apply to you. Familiarize yourself with the breakthrough device program, and the Abbreviated 510(k) and Special 510(k) pathways. Notably, FDA has recently proposed expanding the Abbreviated 510(k) program, which would allow applicants to demonstrate safety and effectiveness to predetermined objective criteria. We will be sure to keep you updated with any news regarding this program. Additionally, the Third Party Review program was enacted by FDA to improve efficiency and timeliness in the review process. FDA has accredited third parties that are authorized to conduct the primary review of a 510(k) for certain eligible devices and then forward their review and decision recommendation to FDA. FDA then has 30 days to issue a final determination.

  4. Keep an eye out for news regarding FDA’s Software Precertification Pilot program. This pilot was implemented to inform the development of a future regulatory model for streamlined and efficient regulatory oversight of software-based medical devices. Manufacturers who have demonstrated robust quality and organizational excellence and who are committed to monitoring real-world performance of their products will be able to streamline their medical device submissions. We will certainly also keep you updated of any news regarding this program.

  5. Use software tools to streamline and automate the regulatory submission process. FDA has launched a Quality in 510(k) Review Program using their eSubmitter software template to format and submit 510(k)s for a small set of eligible applicants. However, while this limited pilot runs, other opportunities exist to streamline your assembling and submitting your 510(k). Right Submission’s software products automate, streamline, and promote collaboration for the regulatory submission process, exporting a formatted and hyperlinked eCopy-ready PDF pursuant to FDA’s style and technical standards. Right Submission ensures consistency and completeness, allowing you to assemble your 510(k) in a more timely and compliant way. Every 510(k) built in our software has passed the RTA review on the first try.

At times, the pathway to clearance can seem long and full of roadblocks, but knowledge and preparedness can get you a long way. FDA is doing their part to streamline the review process and to ensure the rapid clearance safe and effective medical devices, and there are important steps industry can do as well. Both parties need to work together to get lifesaving technologies on the market and to patients. And as always, Right Submission is here to help.

About the Author: Elizabeth FitzGerald, the Director of Regulatory Intelligence at Right Submission, is an experienced medical device consultant who has spent her career helping to bring lifesaving technologies to market faster. She has experience with the full life cycle of device development, through clinical operations, data management and analysis, and regulatory affairs.

The 510(k) Application: If Content is King, then Communication is Queen

You can read the next article in our regulatory insight content series catered specifically to the medical device industry at RIMSYS, our content partner’s blog: The 510(k) Application: If Content is King, then Communication is Queen.

RIMSYS and Right Submission, leading medical device regulatory software solution providers, have teamed up to provide decades of regulatory expertise and behind-the-scenes knowledge to its current and future customer base which includes thousands of regulatory affairs professionals.

Government Shutdown: FDA not accepting 510(k) submissions and proposal to allow submissions likely to fail

During the government shutdown FDA has not been accepting new device submissions, including 510(k)s, as it cannot accept associated user fees - you can read their notice on user fees and staffing levels during the shutdown here. Additionally, as of January 18th, 54% of FDA staff was furloughed or partially furloughed.

While the shutdown will, at some point, end. For now, not only cannot manufacturers not make submissions to obtain FDA clearance on new devices thereby delaying the time to market, but FDA is also accumulating a backlog of ~300 devices a month that will delay clearance time once the shutdown ends. This is not good for industry or patients. But the best thing you can do is continue to work on your submissions. We are ready to support that and encourage you to look at our software platform for submissions that allows submissions to be done faster, done smarter. 100% of the 510(k) submissions built in our platform have got though the RTA review on the first pass - overall only 65% of 510(k) submissions achieve this mark of quality.

AdvaMed, a medical device industry lobbying group, has supported draft legislation to allow FDA to accept and process new device applications during the shutdown. However, it appears that this will fail as it is not supported by house democrats.

Modernizing the Food and Drug Administration's 510(k) Program: Recent Announcement and Guidance

On January 22, 2019 FDA issued a public notice and opened a request for comments on their Medical Device Safety Action Plan specifically with respect to their proposal to publish a list of cleared devices that use older predicates.

We expect that industry will not support this approach and that FDA will receive a large number of comments to that effect. One argument that will be made is that FDA themselves cleared these devices, knowing the age of the predicate, and they were able to meet FDA’s standard for safety and efficacy. So what message is FDA trying to send to the public?

Another is that this may force manufacturer’s to innovate - even without a market need - and R&D costs that are passed on will increase healthcare costs.

Will this be an appropriate or effective way to shift manufacturers to more recent predicates? What about devices for which there is no recent predicate; why force manufacturers to innovate if the marketplace is not asking for it, driving up healthcare costs unnecessarily? 

Although in many cases a 10 year predicate shoudn’t be the BEST predicate device that you can find.

The request for comments does also ask “Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?” We believe there are, encourage people to provide comments to the FDA.

The reliance of the 510(k) system on predicates certainly has its idiosyncrasies. But it is a system of Congress’s and the FDA’s making. We expect the European MDR to reduce the use of predicates in European medical device clearances, by requiring manufacturers to have full access to the technical file of a comparison device. There may well be merit to this approach: if a manufacturer does not have full information about a predicate, does it really make sense to demonstrate safety and efficacy to something with unknowns? It does appear that FDA is considering changing how predicates are used. But if the regulatory pathway for 510(k)s shifts away from predicates, it must shift somewhere. FDA’s answer today is that somewhere is safety and performance based. 

I had the same feeling about the paragraph above, and “We believe there are” – and whether you were then trying to posit this paragraph as one of those alternative actions?

Also this week, FDA published their final guidance on a “Safety and Performance Based Pathway.” (We discussed the April 2018 draft guidance in an earlier blog post.) This pathway, once FDA has the first applicable device types and performance criteria determined, will implement an expansion of the Abbreviated 510(k) pathway. A predicate will still be needed, but rather than carrying out direct comparison testing against the predicate to demonstrate a device is safe and effective, manufacturers will demonstrate the new device meets FDA-identified performance criteria.

We see this as a positive step - it is reasonable for a manufacturer to know what testing and success criteria a reviewer will expect to see in a submission. That information is not always readily available today. Often manufacturers only have access to the publicly available 510(k) summaries of predicate devices, which provide minimal detail regarding the testing conducted. FDA has promised more device-specific guidance. Regulatory professionals and consultants should not have to ‘use their best judgment’ when planning a clearance pathway. While pre-submissions do provide valuable feedback regarding regulatory strategy, they take time and can lengthen time to clearance.

We hope that establishing objective performance testing criteria will lead to the development of safer and more effective devices than comparison to a predicate. The guidance discusses how "substantial equivalence for certain device types may be demonstrated in a way that is less burdensome, but at least as robust.” However, there is a risk that FDA will require more testing than is required today which will increase the cost of bringing a device to market. We also expect that the device types eligible for which this expanded Abbreviated 510(k) pathway will be limited and the program will grow at a slow pace.

As always, Right Submission is here to keep you up to date on the 510(k) program, support your med device and IVD FDA submission needs, and provide software to get submissions done faster, done smarter.

2018: A Year of FDA Regulatory Changes to the 510(k) Process and Why they Matter to You.

2018 was a year filled with regulatory changes as FDA made an announcement on “transformative new steps to modernize FDA’s 510(k) program.” There is much commentary in the trade press on this announcement which we will address later in this blog post. There are also many other changes that have been made to the 510(k) pathway this year, and some may impact you sooner, rather than later. This piece outlines those changes that you should be aware of.

January 2018: 

FDA Publishes Draft Guidance on Laser Products

For those of you with medical devices incorporating a laser, FDA intends to “amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC.” The IEC is the International Electrotechnical Commission, which is the international standards and conformity assessment body for all fields of electrotechnology.

FDA Publishes Final Guidance on their Refuse to Accept Policy for 510(k)s

The Refuse to Accept (RTA) policy is applicable to every 510(k) and this guidance update in January replaced the 2015 guidance. The changes focused on disclosure requirements for combination products that include a drug component. It also published revised checklists and should be your go-to source for ensuring your 510(k) submission gets through the RTA process without delay. A full 1/3 of 510(k) submissions fail FDA’s RTA review on the first cycle, delaying clearance and starting the submission off on the wrong foot with your review team. 100% of the 510(k)s created in Right Submission’s platform have cleared the RTA review on the first pass.

February 2018:

Final Rule on Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices

FDA amended regulations under 21 CFR Parts 807 and 812 in order to ensure quality and integrity of clinical data and to protect human subjects. The FAQ applies to all clinical data and seeks to standardize requirements for what is adequate clinical data, due in part to increased reliance on data collected outside of the US (OUS).   Clinical investigations must comply with good clinical practice (GCP) requirements, include a review by an independent ethics committee, and have informed consent from subjects if the data generated will be used to support an IDE, 510(k), De Novo, or PMA.

Changes to the eCopy process

Also, in February, in an unofficial change not seen in regulation or guidance, FDA is accepting eCopy 510(k) submissions with only a printed cover letter along with the full electronic submission. If you were intending to print your entire 510(k), this change will benefit you.

April 2018:

Draft Guidance on Expansion of the Abbreviated 510(k) Program

Published in April of this year this draft guidance proposes expanding the Abbreviated 510(k) approach for demonstrating substantial equivalence to some well-understood device types. This “least burdensome approach” would allow certain manufacturers to demonstrate substantial equivalence using objective performance criteria rather than through a direct comparison to a predicate device as is traditional in premarket notifications. A predicate would still be identified, but performance testing would be conducted using recognized consensus standards. This would also decrease reliance on comparative testing to what could be old and outdated technology for a predicate device, a theme which will come up later in this document. 

MultiFunction Products

April also included publication of new draft guidance on multiple function products, those devices with several functions some of which being subject to FDA’s regulatory oversight and some which are not.

May 2018:

Draft guidance on Test Reports for Non-Clinical Bench Performance Testing

This draft guidance recommends that for submissions that contain non-clinical bench testing, the complete test report should be included as well as a summary that describes the test preformed, the objective, methods and procedures, justified pre-defined pass and fail criteria, a summary of the results, and a discussion of the conclusions. We hope that you are already utilizing best practices, but this guidance is of value in reviewing this critical section of a submission.

June 2018:

Finalization of 510(k) exemptions for Certain Class II devices

FDA published a notice in the federal register providing premarket notification exemptions for some Class II devices. However, this only impacted a limited number of devices including 25-hydroxyvitamin D mass spectrometry test systems, genetic health risk assessment systems, endoscope disinfectant basins, UV water purifiers, or vibrators for therapeutic use. This is a much smaller set of devices than the more that 1,000 devices exempted in their July 2017 notice.

Draft Guidance on the Q-Sub Program

The Q-Submission Draft guidance will supersede the existing final guidance and provides a summary of methods one can use to obtain feedback and request meetings with FDA with respect to 510(k)s and other submissions. We recommend early FDA interaction for most submission projects to minimize clearance risk to save time and money.  Using a regulatory information management (RIM) system designed specifically for the medical device industry, such as RIMSYS, allows the ability to track notes, decisions, tasks, communications and regulatory documents associated with FDA interactions and other government submissions.

August 2018:

FY2019 MDUFA User Fees Announced

FDA announced the MDUFA User Fees for the 2019 fiscal year (October 1, 2018 through September 30, 2019). Increasing somewhat from 2018, the impact to you will be minimal. The 510(k) MDUFA User Fee increased from $10,566 to $10,953 The fee for a small business increased from $2,642 to $2,738. Much more significant was the change you saw in from 2017 to 2018 where the MDUFA User Fee for a 510(k) more than doubled. 

 September 2018:

Consensus standards

In two publications (Recognition and Withdrawal and Voluntary Standards) FDA provided guidance on the use of voluntary consensus standards in premarket submissions, including 510(k) submissions. This is applicable if you will include a Declaration of Conformity to a FDA recognized standard or for general use.  FDA also provided draft guidance on the recognition and withdrawal of voluntary consensus standards, pertinent if you are seeking to utilize a standard that is not currently recognized by FDA.

eSubmitter software

FDA also announced a Quik Review Program piloting use of their eSubmitter software in a very limited number (38) of well-understood product codes. The eSubmitter software helps to manage submission content and folder structure but does not help to build high-quality content of a submission like Right Submission’s software for regulatory submission (click here to see our online demo or signup for a live demo). In addition, while a full paper copy of a Quik Review Pilot submission is not required, sponsors must still mail in a CD or thumbdrive of the submission according to traditional eCopy requirements. FDA did create a 60-day review goal (versus the traditional 90-day review period) for these pilot submissions and interactive review rather than AI (Additional Information) requests. However, the product categories are ones in which FDA should not have trouble in reviewing in 60 days regardless of submission format. This is unlikely to impact you as the pilot is limited, but it does point to a future of electronic submissions closer to eCTD on the pharma side.

Third Party Review Program

In final guidance, FDA provided a discussion of Benefit-Risk factors considered when determining substantial equivalence in 510(k) submissions for devices that have different technological characteristics than their predicates. FDA feels that this guidance will be helpful if you are seeking clearance for a device through substantial equivalence to a predicate, but with increased risk and increased benefit or decreased risk and benefit compared to the predicate.

The Special 510(k) Program

In draft guidance for the Special 510(k) process FDA announced that they intend to expand the Special 510(k) program to evaluate certain changes to Indications for Use and technology that are currently not within the scope of the program. This will impact you if you are modifying your own legally marketed device. 

Proposed Rule on Electronic Format for Submissions

In September FDA published a proposed rule proposing to amend requirements to remove paper and multiple copies for premarket submissions and replace them with a single electronic format submission. While this is a step in the right direction to improve the efficiency of premarket submission process, we feel that the proposed rule does not go far enough to improve the process.

October 2018:

Consensus standards

FDA updated its lists of recognized consensus standards for use in IVD and other device submissions. This is likely to impact you if you deal with IVD, orthopedic, certain materials (biocompatibility, titanium, poly(lactide) polymers and others) , and some other areas. Of course, utilizing a submission platform such as Right Submission’s 510(k) platform will ensure that you have an up-to-date database of FDA recognized standards to seamlessly pull into your submission.

Cybersecurity Recommendations

Much anticipated, FDA updated the 2014 cybersecurity guidance with draft guidance, defining a two-tier cybersecurity risk categorization system (high versus standard) for devices, and specific documentation requirements for each tier. This draft guidance also introduces a Cybersecurity Bill of Materials which lists software and hardware components that could be susceptible to cybersecurity vulnerabilities.

November 2018:

FDA Statement on Modernizing the 510(k) Program

FDA’s November 26th announcement comes on the tail of some mainstream media focus on the foibles of this forty-two-year-old system by which the majority of medical devices come to market in the largest global market. The Netflix documentary The Bleeding Edge along with the International Consortium of Investigative Journalists report published just one day before the FDA announcement are indicative of the growing public awareness of issues with medical device safety and concerns with the premarket approval process.

CDRH announced it will consider publishing a list of cleared devices and manufacturers that used predicate devices over 10 years older than the subject device, proposed to sunset certain older predicates, and requested public feedback on their approach. The trade press has responded harshly to the public shaming of devices with predicates over 10 years, arguing that they may be the best predicates regardless of age and that FDA themselves has cleared these devices.

Final guidance on this “Safety and Performance Based Pathway,” as FDA has named it, is expected in early 2019 FDA would “like this efficient new pathway to eventually supplant the practice of manufacturer comparing their new device technologically to a specific, and sometimes old, predicate device.” Therefore you may see more of a focus on safety and performance based comparisons to predicates rather than direct comparisons.

And FDA believes its approach may increase De Novo use rather than 510(k)s. Industry has, on the whole, avoided the De Novo pathway. But as technologies evolve, it has become more difficult to identify a predicate device that has similar intended use and technological characteristics to support a substantial equivalence decision. This also aligns with changes in the regulatory environment in Europe, with many experts expecting MDR to result in less use of predicates. With more submissions requiring pre-marketing clinical evidence because of the new requirement for access to full technical information on a predicate, which would be difficult to obtain if the predicate manufacturer is one of your competitors.

December 2018:

MDUFA Performance Data Published

A rich source of data, the MDUFA Performance reports (MDUFA III and MDUFA IV) tell us that FY2018 saw 3,463 510(k) submissions (a small decrease from 3,841 in FY2017). This means that about 10 new devices are coming to market every calendar day and emphasizes the importance of earlier clearance for your devices. You may find the Right Submission free tool that allows you to search FDA’s database of cleared devices by Indication For Use (which you cannot at the FDA website) useful to improve your competitive landscaping and predicate identification and review.

In both FY2017 and FY2018, ~85% of 510(k)s were determined to be substantially equivalent. A flat trend, but alarming in that a great deal of money and effort is being put into 510(k)s that are not successful and therefore not commercially valuable.

In FY2018, 1,108 submissions of 3,283 were not accepted in the first cycle of Refuse to Accept Review. This means that a full 1/3 of submissions are deficient in some way (at least in the eyes of FDA) and we do hope that you consider a software submission platform such as Right Submission’s, with a 100% record of acceptance in the first round of the RTA review, in order to ensure that your submission is administratively complete.

Improvements to the De Novo Pathway

December also saw the publication of the De Novo Classification proposed rule which, combined with the November press release on safety- and performance-based review, may well point to you being involved in more De Novo rather than 510(k) submissions in the future.

Breakthrough Devices Program

To round out the year, on December 18th FDA published their Breakthrough Devices Program guidance document. This program includes aspects of FDA’s Priority Review Program and Expedited Access Pathway. To access this pathway a device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and either represent a breakthrough technology or is a device for which no approved or cleared alternative exists or offer significant advantages over existing approved or cleared alternatives or the availability of which is in the best interest of patients.  If your device meets these criteria then this pathway may offer a faster path to 510(k) clearance (or De Novo or PMA) as breakthrough designation grants priority review and timely feedback.

About Right Submission: 

Right Submission enables medical device regulatory professionals to create higher quality content by bringing automation, project management, and collaboration to regulatory submission creation and publishing.

www.rightsubmission.com 

About RIMSYS: 

RIMSYS is a Regulatory Information Management (RIM) platform designed specifically for the medical device industry.  RIMSYS offers a suite of cloud-based regulatory affairs software solutions to simplify and manage global product registrations, standards, essential principles requirements, regulatory documents, changing regulations and more.

www.rimsys.io

 About the Author:

istanbul+photo.jpg

Marek Herrmann-Nowosielski, the CEO of Right Submission LLC, has had an extensive career leading R&D, product development, operations, engineering and commercialization organizations and activities for established and venture funded companies in highly regulated industries, including leadership roles at GE, DuPont, Oasys Water and Heartland Technologies.

He is a Fellow of the Institute of Chemical Engineers, a registered Professional Engineer and holds MA, MSc, MEng and MBA degrees.

INNOVATIVE MEDTECH REGULATORY SOFTWARE COMPANIES TEAM UP. Right Submission and RIMSYS collaborate on new content series for the medical device industry.

RIMSYS LLC and Right Submission LLC, leading medical device regulatory software solution providers, have teamed up to release a regulatory insight content series catered specifically to the medical device industry. Combining decades of regulatory expertise and behind-the-scenes knowledge, this new partnership will provide unparalleled value to its current and future customer base which includes thousands of regulatory affairs professionals.
The medical device industry is rapidly evolving, and regulatory affairs professionals need to adapt to changing regulations to ensure compliance and increase efficiency. RIMSYS LLC and Right Submission LLC have created innovative and disruptive software solutions specifically catered to the medical device industry.

“We are extremely excited by this opportunity. This partnership signifies a shift in the current thinking of how medical device companies need to manage their regulatory information, from worldwide submissions, country entrance requirements, and proactively monitoring the regulatory landscape,” said James Gianoutsos, Founder & President of RIMSYS LLC.

RIMSYS LLC and Right Submission LLC complement each other perfectly. Each software solution provides immediate value to its users and both companies are dedicated to increasing regulatory efficiency and compliance throughout the medical device industry.

“We see vast potential for improving the quality and reducing the cost of medical device regulatory operations – bringing life changing technologies to patients faster and allowing our clients to win in the market. It is a powerful collaboration to work with RIMSYS, who like Right Submission, is focused on supporting medical device regulatory professionals with highly impactful software solutions,” said Marek Herrmann-Nowosielski, Co-founder & CEO of Right Submission LLC.

See the full press release

Right Submission Exhibiting at 2018 RAPs Convergence

Right Submission is exhibiting at the upcoming 2018 RAPS Regulatory Convergence in Vancouver, October 2 - 4. We will be showcasing our suite of SaaS-based regulatory submission solutions.

Stop by our booth in the exhibition hall for a demo of our current offerings, and ask for a preview of our upcoming products in development. Looking forward to seeing you there.

Right Submission announces the launch of our Regulatory Intelligence module.

Here you can search our proprietary database of over 147,000 FDA-cleared 510(k)s and De Novos, including the first available Indications for Use search tool, which is invaluable for both regulatory work and competitive analysis. 

  • You can search via Keyword or Indications for Use to return results specific to your product, and view Indications for Use results right in the browser.
  • You can add additional parameters to refine your search as you go, so once you've executed an Indications for Use search, you can filter by a specific Product Code, Review Panel, or Regulation.
  • You can save searches and return to the platform to update results or explore alternative regulatory pathways.

 

reg intel screen1.png

Right Submission launches our Regulatory Foundations Module

This free tool allows the experienced and novice user to assess and document their medical device FDA regulatory pathway decision making process and supports regulatory strategy development.

The tool includes access to our proprietary database of >147,000 FDA regulated medical devices and introduces a documentable search of the Indications for Use in our database - the first available IFU search tool which is invaluable for both regulatory work and competitive analysis.

Right Submission at the Medical Device Technology Exchange Conference and Exhibit in Seacaucus, NJ

Right Submission and Greenlight Guru will be hosting a workshop, 510(k) Best Practices: Applying Risk Management and Design Controls. 

In this workshop you will learn a step-by-step approach for identifying the regulatory pathway, testing requirements and verifying these requirements before you even begin your testing. This is all part of an integrated approach to planning of design and risk management for medical devices.

You can learn more about the workshop, and register for the event, by clicking here.

Right Submission Announces the Release of our CSR Product

This software guides you through the creation of a CSR pursuant to the ICH E3 guidelines for Clinical Study Reports. It helps build high quality content and allows for easy integration and management of your clinical data analysis and Section 16 appendices. You can then seamlessly merge your completed CSR into the 510(k) platform for premarket clearance.

Upcoming MassMEDIC Webinar: FDA Medical Device Submissions – You’ve Got Legal Questions – We Have the Expert

Wednesday, September 27, 2017 @ 12:00 pm - 1:00 pm

We have teamed up with MassMEDIC and FDA Attorney Jeffrey N. Gibbs of Hyman, Phelps & McNamara, P.C. to bring you a webinar focused on legal questions you might have relative to FDA product submissions.

Questions such as:

  • From a legal perspective what are common mistakes submitters make in FDA submissions?
  • What recent legal cases has CDRH been involved in and how have they turned out?
  • Is the confidentiality text we copy/paste into our submissions legally binding and what happens if we don’t include it? When should we include it?

This is an extraordinary opportunity to get your legal questions about FDA device submissions answered.