US FDA Consulting for Medical Device and IVD Manufacturers

1. US FDA Consulting for Medical Device and IVD Manufacturers As we all know that some of the US FDA regulations are extremely specific and special for medical devices and IVD which are supposed to be sold in USA. So even for Global manufacturer, approval in many countries and selling them would not just automatically gives approval for sale in USA. Recommending US FDA consulting to medical device and IVD manufacturer may look sales gimmick so let us first look what are the requirement and corresponding regulation or documentation. 510K submission, IDE (investigation device exemption) submission or clinical trials, for Classification query and resolution, if manufacturer is outside then effective representation, Audits and audits of suppliers, form 483 and warning letter resolution, apart from other general guidance on day-to-day affairs like pre submission meeting, 21 CFR part 820 understanding. There are enough guidelines and documentations are available like some specific cases of IVD classification, justification risk class judgement, preparing rational. Guidance documents are good enough. So why do we need US FDA consulting? Guidance and reference documents are available everywhere other than USA too. However, studying them and interpreting the same to our requirements is skilled task. Company may hire regulatory experts but unless that expert has vast practical experience of handling of all above issues successfully, it becomes risky to just dwell on

2. inhouse regulatory advice. Compliance is key in medical device business and timeliness is also key to success of business so delay in resolving issues can cost dearly for company. IVD is particularly importantdevice, and its classification is very important. It happens sometimes that local national authority has accepted lower classification of IVD locally but now that is not acceptable for US market where GTHF guidelines are used, and its interpretation does not allow this classification. Whole new exercise will be needed. There are regular updates and changes in the regulation which all organisations are not aware of and not complying to it becomes an issue. (Recently US FDA issued and update on potential biocompatibility issue on NuVasiv specialized orthopaedics where they have informed about titanium based precise devices and recall for stainless steel-based devices). Consider managing 483 and warning letter. Since you received 483, it speaks some system lacunae. Even we accept 483 but getting a warning letter is big lacunae. Understanding of those observation during audit was not enough despite closing meeting discussion which resulted into this situation. One should also consider do we want to go for first time right? Do you need success of first-time acceptance of 510K, Success in IDE exemption submission which can save your time and resource? Based on your organisation competency, it is recommended that one must go for US FDA regulatory consultants or US FDA Medical device consultants for complex issues managing as discussed above. It is also advantageous for your regulatory team and other experts in organisation as they get an opportunity to collaborate with these consultants and discuss with them, understand their rational and logic, learn why they did not think in that direction. Remember US FDA regulatory consultants or US FDA medical device consultants are experts and advising many such companies and have experience where your case may be unique to you while they may have already managed such case of some other organisation.

3. IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.