Our software and experts get your medical device through FDA clearance and avoid costly setbacks. Whether it is through a PMA, 510(k) or 510(k) exempt.
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Formly is the leading platform to manage your MDR compliance. Expert guidance paired with a modern software platform gets you certified fast.
We know we have the back office covered with Formly. They are hands on and make our MDR compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.
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The certification process for medical devices is centered around meeting the regulatory requirements specified by the country you wish to certify your device in. Companies looking to certify their medical device in the EU (CE mark) or in the US (FDA approval / clearance) should typically go through the following steps:
-determine their product risk class and regulatory requirements according to EU Medical Device Regulations (MDR) 2017/745 or US FDA 21 CFR,
-establish a Quality Management System under ISO 13485 for EU or 21 CFR Part 820 for US FDA,
-create your technical documentation for your device according to the standards relevant for your region,
-undergo an audit your quality management system and technical documentation (unless Class I in EU or 510(k) exempt in US),
-maintain post-market requirements for the device for surveillance and device changes.
Formly’s software helps you with all of these steps.
These differ according to FDA submission types.
- Exempt Devices: Many Class I devices and some Class II devices are exempt from premarket submission but must comply with general controls and proper documentation. Preparing these can take a few weeks to months.
- 510(k) Premarket Notification: Usually Class II devices fall under a 510(k) submission. It includes devices demonstrating substantial equivalence to an existing legally marketed device, the FDA review process typically takes 90 days after submission. Preparing the submission, including testing and documentation, may take 6-12 months.
- Premarket Approval (PMA): Typically for Class III devices but some rare Class II devices need PMAs as well. This is a more rigorous pathway to approval. It involves clinical trials, detailed documentation, and FDA review which FDA has a goal of 180 days for each review.
- De Novo Classification Request: For any novel devices without a predicate, the De Novo process may take 6-12 months depending on device complexity and the quality of the submission.
- Breakthrough Device Designation: Designed for innovative devices addressing unmet needs, this program offers expedited interactions with the FDA. While timelines vary, the goal is to significantly reduce the time to market compared to traditional pathways.
A pre-submission (Q-sub) meeting with the FDA is a voluntary opportunity for medical device developers to receive feedback on regulatory pathways, testing plans, or submission strategies.
A Q-sub meeting is highly recommended if you need FDA feedback on your regulatory pathway, testing requirements, or study design, especially for novel or complex devices. It’s a key opportunity to address potential issues early and align with FDA expectations before you go through the submission process.
If you're thinking of applying for a q-sub, consider the following timelines from the day you submit.
