Regulatory Submission

Learn how others have submitted their medical device products to governing bodies all over the world!

  • 17 Topics
  • 41 Replies

17 Topics

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caitlinNew Participant
asked in Regulatory Submission

Clinical Trials in EU with non cleared devices

Hi All, We are looking at how to expand to run clinical trials in Europe before receiving CE mark. Has anyone had experience with this process? I am not sure what interim certification is needed with EU or is it all through the local hospitals. Also, when shipping the device to the EU, are there special customs forms that need to be filled out to send a uncertified product? Thanks!Caitlin

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C
2 days ago
Etienne
EtienneCommunity Manager
asked in Regulatory Submission

MDR Certification

I’m curious how many people are out there that have achieved their EUMDR Certification.If your company has managed to pull this off, would you be open to joining a discussion/RoundTable to talk more about the roadblocks you faced, and advice you might have for companies that are a few steps behind you?Let me know, either in the comments or private message me! Thanks!

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Etienne
1 month ago
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caitlinNew Participant
asked in Regulatory Submission

Submitting Clinical data for labeling expansion

Hello, I am looking into trying to expand our labeling to include some clinical trial results so we can use them in marketing material.  Is there a good guidance that explains the process for devices? Would I need to submit a full trial report for a labeling claim (rather than an efficacy claim)I have found the guidance for Acceptance of Clinical Data to support submissions Q&A, but was not sure if there was something better. Thank you for your help,Caitlin

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C
3 months ago
Etienne
EtienneCommunity Manager
posted in Regulatory Submission

Recording of the Nov. 30th RoundTable on Clinical Evaluation Reporting

Here is the recording of the Nov. 30th RoundTable discussion on Clinical Evaluation Reporting with @Keith Kallmes, @Ross Meisner, & Carrie Hetrick! 

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K
3 months ago
Etienne
EtienneCommunity Manager
asked in Regulatory Submission

U.S. Clinical Evidence

I received an anonymous question and wondered if I could get some help! If I have a device currently marketed in the US and I want to start marketing in the EU, is clinical evidence that comes only from the US acceptable for notified bodies or does clinical evidence also need to include EU and/or other parts of the world?@joningib  @Keith Kallmes @BenB are you able to help?

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M
4 months ago
Etienne
EtienneCommunity Manager
asked in Regulatory Submission

Are IFU's required for Class 1 devices under EUMDR?

I received an anonymous question, wondered if anyone can help here? We’re updating an MDD Technical File to MDR and the products from the previous technical file didn't have IFUs. They are class Is and IIa instruments and accessories. Originally, we supplied a symbols legend with these devices, but no instructions.  I’m the "project manager" for this project and I have IFU development on my timeline, which has been questioned by my manager… They are saying that an IFU isn't needed for these devices. I responded with section 23.1 of the GSPR saying that medical devices entering the European Union under MDR must have an IFU, and he said nowhere in the MDR does it say that an IFU is required for class Is or IIa devices. At a previous company, we had a similar issue where we were putting together technical documentation for a group of accessories and these didn't have an IFU either and our European team had us develop IFUs from nothing, which was a huge pain.  The class Is products are sim

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B
5 months ago
mcorbo
mcorboNew Participant
asked in Regulatory Submission

Accessory to a medical device?

Two-part question:1) We have an FDA-cleared neonatal phototherapy device (Class II, 510(k) in 2019). We are in the process of launching a line of swaddling garments (not medical devices on their own) that can be used to comfort neonates in the NICU and/or in other areas of the hospital. As long as we are clearly not marketing the two together and the garment is not intended to be used with our phototherapy device, the two products can co-exist, correct?2) In the future we wish to explicitly market the two products together. We will have evidence to support claims that the garment supports and augments the performance of the phototherapy device, we will have established a DHF and other design control measures for the garment, and we would update our IFU for the phototherapy device. We are lead down the path of a new 510(k) due to changes in contraindications (source: FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device). Does the fact that we will have previ

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mcorbo
5 months ago
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caitlinNew Participant
posted in Regulatory Submission

Including Machine Learning Algorithms in 510(k) submissions

Hi, I am working on a 510(k), which would introduce some machine learning models into the data processing pipeline of our software (which is part of a medical device, not SaMD). We did have a pre-sub meeting with the FDA, and they seemed to want a huge amount of details related to every possible aspect of the data collection and algorithm development.  I am trying to write up the description now.  I was wondering if anyone has successfully submitted a device that includes machine learning models and how it went. Is there any advice I could use to hopefully not get a million questions back from them after submission.  Also, on a curiosity point, we opted not to submit with a Pre-Specified Change Control Plan, as that would have required us to use the De Novo pathways.  Thanks for the help!Caitlin

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C
7 months ago
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TeenewNew Participant
asked in Regulatory Submission

Declaration of Conformity of 510k significant chane

Hello,I am submitting a new 510k for a significant Change, do I need to do all the conformity testing again? even when the previous standard we declared conformity to, with supporting test are still on the FDA  recognize standard data base? 

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Etienne
7 months ago
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SibelNew Participant
asked in Regulatory Submission

3 questions related to software in medical device

1: If a medical device is working with a software,Is this software accepted as a device incorporating/utilising specific technologies/elements for this medical device?2: Is the medical device only in technical field of general active but not implantable medical device since this medical device cannot be operated without software? OR Is this medical device has 2 technical areas as general active but not implantable device and additionally device utilising software?3: Is the technical code for this medical deviceMD1301 Monitoring devices of non-vital physiological parameters? OR MD1301 Monitoring devices of non-vital physiological parameters with MDS 7010 - Medical devices incorporating software / utilising software / controlled by software?

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S
8 months ago
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mArcherParticipating Frequently
asked in Regulatory Submission

Do we still need Form 3654?

We’re putting our 510k together - do we still need the Form 3654 “Standards Data Report?”I can’t find it on the FDA website.

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Etienne
8 months ago
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MICHELLENew Participant
posted in Regulatory Submission

State of the art section for the clinial evaluation report

HiA consultant told us that the state of the art section is the first thing that the auditor will look at in the clinical evaluation report, and if they feel that there is not sufficient substance or dont agree with the approach, that they may not review the file at all. Could you maybe do a talk on state of the art?

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Etienne
9 months ago
J
Jason ChakroffNew Participant
posted in Regulatory Submission

Inventory Management Software

Does anyone in the community have recommendations for Inventory Management Software programs? We are looking for something that can help us maintain traceability of our materials through our receiving/manufacturing processes, and also help us track finished good movements from shipping to trunk stock, consignment, and customers.  We are current evaluating a program called “Fishbowl” for this, but I figured I’d ask to see if any other programs standout. Thanks!

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MariaRiccobono
9 months ago
Etienne
EtienneCommunity Manager
posted in Regulatory Submission

How can the software be the only portion of a device that falls under design controls?

My understanding is that for devices like the Apple Watch, the app software that detects irregular heart rate is considered to be SaMD (software as a medical device) and is therefore subject to design controls. The question is, is the device itself covered by Design Controls? Is there a DHF for the physical components of these devices (such as the Apple Watch)? It would seem that the diagnostic ability of an app is only as good as the information that it is given, so I struggle to understand if a device is not held to the same standards as the software analyzing the data. Thanks!

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Etienne
10 months ago
Etienne
EtienneCommunity Manager
posted in Regulatory Submission

When to push back on FDA?

I’ve heard some Regulatory experts say that they will push back on FDA on certain issues.One example I’ve heard... If a company changes their device and documents the change in a Letter to File, and then has another change, another Letter to File, and so on… Eventually they may file a “catch-up” 510k, using the special-510k. If the reviewer kicks it back on administrative reasons, some Regulatory experts will push back on FDA.When is it realistic/beneficial to push back on a regulatory agency? How do you make this determination, and then (once that determination is made) how can you execute this decision/pushing back without burning future bridges with FDA?

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Etienne
10 months ago
WADE SCHROEDER
WADE SCHROEDERCommunity Manager
asked in Regulatory Submission

Where to justify the software applications that don't require validation

Certain software applications that medical device companies use aren’t required to be validated because they are low/no risk or don’t impact the product.  Where do you recommend that these justifications for not requiring validation be listed?  In the Master Validation Plan, in a separate memo, or somewhere else?

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Eric Henry
10 months ago
Tim Hickle
Tim HickleDirector of Content and Community
posted in Regulatory Submission

How are you preparing to keep your product to stay on-market post-EUA?

Just listened to this episode of the Global Medical Device Podcast on post-EUA regulatory strategy. Wanted to get others’ thoughts. If you have a device that got EUA clearance, what’s your regulatory strategy moving forward? 

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Tim Hickle
1 year ago

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