What should I reckon before getting an approval for a medical device in US?

A medical device maker has to go through a lot of preparation and documentation before submission to regulatory authorities.

Here are the steps you must consider for getting the nod from US FDA. Here is an overall gist of the FDA process—the actual PMA process of getting approvals is certainly tedious.

• Phase A: You must first ascertain the segment and classification of your medical device by searching the FDA classification database using appropriate key words or by finding a different one with a similar technology, usage, and specifications. You must consider the 3 (three) letter code of the product and 7 (seven) digit regulation figure linked to the predicate devices you identify. Ensure you use 513(g) if the segregation is unclassified so that you can request one from FDA.
• Phase B: Medical devices pertaining to Class 1 must abide by the Quality System Regulation (QSR’s GMPs) other than Part 820. Most Class I devices have to comply with the QSR (GMPs), except for Part 820. You must implement a QMS (Quality Management System) that is on par with FDA’s QSR; you will find this in 21 CFR part 820.
• Phase C: You will require clinical studies for innovative Class II and all Class 3 devices; ensure to secure a pre-pre-sub(pre-submission) feedback report from FDA.
• Phase D: Apply for IDE (Investigational Device Exemption) if the clinical studies are required and develop CTP (Clinical Trial Protocol) and perform studies. Note that with an IRB approval non-significant risk studies may be done.
• Phase E: There are submission fees that you need to pay in the PMA (Post-Market Approval) for class Class II and Class III. For example, in the case of Class II devices, ensure you first prepare and submit 510(K) PMA and pay the fee. This applies to Class III devices as well.
• Phase F: All the members involved in the CRO project should comply with FDA QSR, the reason being that for Class III devices, there are inspections of facilities of all main providers who are part of the research, development, design, and production of the medical devices.
• Phase G: FDA’s response vary based on the class of device. For example, in the case of Class 3 you get an online approved letter for the approval of PMA and you get an online clearance letter when the FDA issues you 510(k) clearance.
• Phase H: By this stage now, your medical device must meet the QSR standards; however, the FDA will not investigate Class 1 or Class 2 compliance before you register your device. And FDA will do random checks and provide Form 483 if the device does not comply.
• Phase I: If you are non-American medical device manufacturer with a presence outside the US then you have the option to a utilize a local US authority to represent you who is appointed by the FDA.
• Phase J: Ensure you enlist your medical device and register by FDA Unified Registration and Listing System as per 21 CFR section 807 and pay fees for registering the facility/device and renew it on a yearly basis.
• Phase K: Once you are prepared to put your device on the market then FDA will publish details of your device’s registration its website; moreover, the device authorization will cease if you make updates to the design and its actual purpose of use.

US Medical device approval process bogging you down? Talk to Pepgra CRO experts today.

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