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。
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