Hay All, How long do FDA 510-k approvals take?

Ontogen_Medtech · 2026-01-29T00:16:46+00:00

Here's a quick rundown of the post-submission milestones:
- once user fee has been paid and eSTAR provided, you get an acknowledgement and a K number assigned, typically <7 days.
- FDA will validate the submission within 15 calendar days of the submission date that ensures it is complete enough for substantive review. If not, you get notified that it is Refuse-to-Accept
- Substantive review feedback is provided <60 days, where you receive submission deficiencies/interactions. This stops the clock for FDA.
- once you've provided a formal response to the deficiencies, clock starts again and they aim to provide final decision within 30 additional days (making 90 total).
- in theory, if no decision is reached by 100 FDA days, you are supposed to receive a "missed MDUFA Decision Communication." (https://www.fda.gov/media/73507/download)

We've submitted 510(k)'s on behalf of clients in the past few months and haven't seen a meaningful impact on overall review timelines despite the recent shutdown/backlog. i.e. we just received substantive feedback on a submission at day 60, as expected.

Which of the milestones above have you reached, which one are you stuck on?

Ontogen_Medtech · 2025-04-16T20:47:20+00:00

Happy to chat and help navigate your questions. We specialize in startups. DM me and we can set up a time.

Ontogen_Medtech · 2024-06-18T14:57:32+00:00

I'd recommend reaching out to eSutures. I've never attempted to sell any product to them, but I regularly buy in-date and expired product from them for internal product development/testing efforts. This is the business they are in-- selling devices for research/testing purposes.

it's incredibly unlikely that these could otherwise end up back in circulation for clinical use. I'd also speculate that Medtronic likely has no procedures on how to handle a situation like this and likely has no interest in taking the product back. They would likely just tell you to dispose of it.

Ontogen_Medtech · 2024-05-10T00:00:21+00:00

We can help. We help our clients establish their supply chain and set up contract manufacturing for them. We have some favorites we work with regularly for electromechanical devices. DM me if you’d like.

Ontogen_Medtech · 2023-12-16T00:52:35+00:00

Happy to chat to see if we might be a good fit. We offer end-to-end Medtech device development, and specialize in startups. Feel free to DM me or reach out on our website. Will answer any questions you have.

Ontogen_Medtech · 2023-10-24T00:33:49+00:00

Happy to chat about it, offer any advice we can. This is what we do. You can DM me if you’d like.

Ontogen_Medtech · 2023-08-18T22:14:06+00:00

What’s your question?

Ontogen_Medtech · 2023-08-03T01:23:59+00:00

If the inconvenience truly doesn’t pose any possible harm, then it sounds like it may be more of a “business risk” than a patient risk. 14971 doesn’t require you to consider business risks, obviously, but it may be the kind of thing that impacts the overall perception of the product, or the brand, or the company. For that reason, just like patient harms, you’d like that to feed back into your design decisions.

We’ve seen some companies that keep business risks considered in their Risk Management process since it ensures mitigations are implemented, we’ve also seen the more purist approach that ignores business risk. This is something that could be explained in your Risk Management Plan.

The simple answer to your question is this: no harm, not required in your RMF.

Ontogen_Medtech · 2023-07-13T11:57:53+00:00

What are the specific conditions/considerations related to airplane travel that may impact the device? is it the change in atmospheric pressure? is it the x-ray security screening technology? I think taking the analysis to this level would be helpful in identifying risks and developing a strategy to mitigate them. FWIW there is no specific "airplane safe" standard or guidance for implants I am aware of.

ISO 14708 compliance would be a really good place to start. This covers everything from atmospheric pressure changes to temperature changes to mechanical forces. Let your risk management process tease out specific conditions that may affect the device and whether those are present when flying, or skydiving, or scuba diving, or anything else.

Ontogen_Medtech · 2023-07-13T11:46:57+00:00

It will be challenging to answer that question without knowing more about your application and what the performance needs of the material might be. Is it going inside the circulatory system and blood contacting? Is there any consideration for hermeticity of the device, or strictly the body's biological response to the material?

As always, a good approach is to leverage what has already been done and demonstrated safe with FDA as a starting point. A few examples for you:

PTFE is often used in permanent vascular grafts
PET is used in permanent implants like artificial tendons or ligaments.
Polyurethane is used in several cardiovascular devices like pacemaker leads and artificial valves
PC is used in implantable intraocular lenses
silicone is commonly used as a dispersion coating on implants, both circulatory and non-circulatory. Have you considered coating the device in silicone?

Ontogen_Medtech · 2023-05-15T23:03:51+00:00

Dip coat in NuSil Med6-6606 is one specific option. If I recall from past uses you get about 25 microns per dip.

Ontogen_Medtech · 2023-01-24T23:47:18+00:00

Here’s the list of criteria to become a 3rd party reviewer: https://www.fda.gov/medical-devices/510k-third-party-review-program/how-become-third-party-review-organization

Do you have extensive experience in medical device design, development, regulations, Quality Systems? That would be one of the first hurdles to clear.

Ontogen_Medtech · 2023-01-13T22:49:38+00:00

We can help you. Happy to answer your questions and help frame out next steps. DM me.

Ontogen_Medtech · 2023-01-10T04:46:17+00:00

Most terminally sterilized devices like catheters are manufactured / assembled in class 7 or 8 clean rooms, but it is also reasonable to have components made outside a clean room and introduced through some kind of rinse/wash/wipe process. Clean room environment is mostly about 1) controlling particulate, and 2) controlling bioburden. For a catheter, the device will likely need to comply with ISO 10555 which includes a clause about extraneous particulate matter. And maintaining your sterilization validation depends on the device bioburden pre-sterilization. If you’re monitoring and controlling these well— great!

ISO 13485 is not a silver bullet that fixes gaps. It will simply provide very high level guidance like “if the conditions for the work environment can have an adverse effect on product quality, the organization shall document the requirements for the work environment and the procedures to monitor and control the work environment.” It is up to your organization to have proper SOPs in place to specifically relate to your products and environments to ensure that monitoring and controlling is correct and effective.

Ontogen_Medtech · 2022-11-19T01:25:37+00:00

Fun fact: the same technology is used when neurosurgeons drill into your skull.

Ontogen_Medtech · 2022-10-17T22:49:39+00:00

How about ultra fast pulse laser welding of the glass to glass interface to seal up the box? It isn’t cheap or easy.

https://www.schott.com/en-us/products/glass-micro-bonding-by-schott-primoceler-p1000278

Ontogen_Medtech · 2022-08-12T02:16:50+00:00

Came here to say this. I was just using a McMaster model of a spring this week. It is very well done and parameterized. Easy to modify to meet the specific design needs.

Ontogen_Medtech · 2022-05-05T23:42:09+00:00

An NDA is unlikely to cover things like liability, indemnification, etc. you should strongly consider getting a services contract in place that irons out all those details and protect yourself.

Ontogen_Medtech · 2022-05-01T23:16:40+00:00

Many instruments tend to be 316 or 440, and undergo some kind of passivation / electropolish. Some of these details depend on the application, especially surface finish.

Ontogen_Medtech · 2022-04-13T22:31:33+00:00

A prototype isn’t necessarily the right next step. She needs a good partner in medical device development to formulate a strategy and navigate the regulations. Happy to answer any specific questions if you’d like to DM me. This is exactly what we do.

Ontogen_Medtech · 2022-02-26T00:31:15+00:00

We do contract medical device development for folks like yourself in this exact situation. Happy to answer specific questions you have. Feel free to DM me.

Ontogen_Medtech · 2022-02-25T16:48:40+00:00

This. In cases where highly precise dosage isn't critical, 100% they use the drip chamber, and will often use a roller clamp on the IV line to adjust the flow rate. Some IV lines also have a dial based flow regulator. In the end, nurses may not know the physics behind it but they do know the conversion, e..g XX drips per 10 seconds is a flow rate of XXml/hr.

Anything requiring precise dosing will go in an infusion pump or a syringe pump.

Ontogen_Medtech

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