FDA査察対応結果

FDA査察を終えて

筆者は、今月ある医療機器メーカのFDA査察に立ち会った。
結果はNAI(No Action Indicated:指摘ゼロ)であった。つまりFDA Form 483は発行されなかった。
良好な結果を得られた要因はもちろん緻密な準備周到であるが、それだけではない。

当該医療機器メーカにとっては初めてのFDA査察であった。初回の査察ではレベルII査察(包括査察)が実施され、当該企業のデータベースをFDAに作成することが主な目的とされる。
したがって、一般的に大きな指摘が出されないことが多い。

FDA査察は3回目が正念場

ちなみにFDA査察は3回目が正念場と言われている。
上述の通り、1回目と2回目は包括査察(レベルII)査察のため、製造所のデータベース作りが目的である。
FDAのInvestigation Operations Manualでは、2回連続指摘が無い場合、3回目の査察官を見直すことが明記されている。

In order to facilitate on-the-job training, multiple points of view, and perspectives of firms being inspected whenever practical, those with assignment authority, should consider assigning different Investigator/s or different Lead Investigators at different times.

This is recommended particularly when there have been multiple sequential NAI inspections or  when the firm’s management has been uncooperative.

FDA Form 483発行件数の減少について

米国では2009年に民主党政権(オバマ政権)となり、FDA査察は米国内外ともに厳しくなった。
ワーニングレターの発行数も倍増した。
しかしながら、共和党政権(トランプ政権)になってからは、FDA Form 483とワーニングレターの発行件数は激減した。
2017年のワーニングレター発行件数は米国内外を合わせてもわずか42件である。
FDA長官は大統領が任命するため、政権が代わればFDAの方針も変わる。

しかしながらそれだけではない。これまでFDAは多くのFDA Form 483(指摘)を発行してきたが、これに対する業界の不満や不信感がつのっていることも理由に挙げられる。

米国市場におけるデバイスラグ問題

FDA査察における指摘以外にも、510(k)クリアランスに時間を要することについても業界の不満がたまっている。
そもそもEUでは医療機器の上市は自己宣言(認証機関の審査のみ)であり、規制当局の審査は受けない。
そのため製品を早く市場に投入することができる。
しかしながら米国では、クラスII、III医療機器はほぼすべてFDAによる審査が必要である。
これがいわゆるデバイスラグとなっているのである。

FDAは510(k)審査の迅速化についても対応を急いでいる。

【お知らせ】
イーコンプライアンスではFDA査察対応セミナーをオンラインで配信しています。(有料)
詳しくはこちらをご参照ください。

https://www.youtube.com/watch?v=zIHXobIP_vo

関連VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
FDA査察対応セミナー
セミナービデオはこちら

Related post

Comment

  1. It is actually a great and useful piece of information. I am satisfied that you simply shared this helpful information with us. Please keep us informed like this. Thank you for sharing.

  2. It’s really a cool and helpful piece of information. I am glad that you shared this useful info with us. Please keep us up to date like this. Thanks for sharing.

  3. I believe you have mentioned some very interesting points, thankyou for the post.

  4. It is in point of fact a great and helpful piece of info. I’m happy that you shared this helpful info with us. Please stay us up to date like this. Thank you for sharing.

  5. Great line up. We will be linking to this great article on our site. Keep up the good writing.

  6. What Is Sugar Defender? Sugar Defender is made of natural plant-based ingredients and minerals that support healthy blood sugar levels.

  7. There is evidently a bundle to identify about this. I suppose you made various good points in features also.

  8. he blog was how do i say it… relevant, finally something that helped me. Thanks

  9. Java Burn: What is it? Java Burn is marketed as a natural weight loss product that can increase the speed and efficiency of a person’s natural metabolism, thereby supporting their weight loss efforts

  10. You are my aspiration, I possess few web logs and infrequently run out from to brand : (.

  11. What i do not realize is actually how you’re not really a lot more neatly-appreciated than you may be right now. You are so intelligent. You recognize thus considerably with regards to this subject, produced me personally consider it from so many various angles. Its like men and women are not interested except it?¦s something to do with Woman gaga! Your individual stuffs great. Always maintain it up!

  12. Hello! I’m at work browsing your blog from my new iphone! Just wanted to say I love reading through your blog and look forward to all your posts! Carry on the fantastic work!

  13. Hmm is anyone else having problems with the pictures on this blog loading? I’m trying to find out if its a problem on my end or if it’s the blog. Any responses would be greatly appreciated.

  14. What i do not realize is in reality how you’re not really much more neatly-preferred than you might be now. You’re very intelligent. You recognize therefore considerably with regards to this matter, produced me in my view imagine it from so many numerous angles. Its like men and women are not fascinated unless it¦s one thing to do with Woman gaga! Your own stuffs great. At all times deal with it up!

  15. hi!,I like your writing so a lot! proportion we communicate extra about your article on AOL? I require an expert in this area to solve my problem. May be that is you! Taking a look forward to see you.

  16. I like this blog very much so much great information.

  17. Do you have a spam issue on this blog; I also am a blogger, and I was wanting to know your situation; many of us have developed some nice methods and we are looking to exchange solutions with others, why not shoot me an email if interested.

  18. Hello there, just became alert to your blog through Google, and found that it is really informative. I’m going to watch out for brussels. I’ll be grateful if you continue this in future. Numerous people will be benefited from your writing. Cheers!

  19. I as well as my pals have been looking through the best strategies located on your web blog then at once came up with a terrible feeling I had not expressed respect to the web site owner for those strategies. The ladies came excited to learn them and have now without a doubt been using them. Many thanks for getting well considerate and for going for certain high-quality subject matter millions of individuals are really eager to discover. My sincere regret for not saying thanks to earlier.

  20. This website is my inspiration , rattling excellent style and design and perfect written content.

  21. Wow! Thank you! I continually needed to write on my blog something like that. Can I implement a portion of your post to my blog?

  22. What is Aizen Power? Aizen Power is an all-natural supplement to improve overall male health.

  23. so much superb info on here, : D.

  24. Keep functioning ,fantastic job!

  25. Would love to constantly get updated outstanding web site! .

  26. Very interesting info !Perfect just what I was searching for! “It’s not the having, its the getting.” by Elizabeth Taylor.

  27. Well I really enjoyed reading it. This post offered by you is very effective for correct planning.

  28. I am not sure the place you’re getting your info, however good topic. I needs to spend a while finding out much more or understanding more. Thank you for great information I used to be looking for this info for my mission.

  29. Howdy very cool website!! Man .. Excellent .. Superb .. I’ll bookmark your blog and take the feeds also…I’m glad to search out so many helpful info right here in the put up, we want develop extra techniques on this regard, thank you for sharing.

  30. Wow! Thank you! I continually wanted to write on my blog something like that. Can I implement a fragment of your post to my website?

  31. It is appropriate time to make some plans for the future and it’s time to be happy. I’ve read this post and if I could I want to suggest you few interesting things or tips. Maybe you could write next articles referring to this article. I wish to read more things about it!

  32. Sweet web site, super pattern, rattling clean and utilise friendly.

  33. This is the right blog for anyone who wants to find out about this topic. You realize so much its almost hard to argue with you (not that I actually would want…HaHa). You definitely put a new spin on a topic thats been written about for years. Great stuff, just great!

  34. Would you be considering exchanging links?

  35. I am only commenting to make you be aware of of the cool experience my princess had reading through your blog. She noticed several details, which include what it’s like to have a very effective helping mood to get many people easily gain knowledge of several very confusing subject matter. You actually exceeded our own expected results. Many thanks for displaying those practical, dependable, educational and easy guidance on the topic to Tanya.

  36. Nice blog right here! Also your website so much up very fast! What web host are you the use of? Can I am getting your associate hyperlink to your host? I wish my site loaded up as fast as yours lol

TOP