美國FDA於八月初公告2014年對小型企業(Small Business)收費標準,公告內容與2013年無太大差異,僅針對收費標準做了修正,每項申請費用都提高不少。

Medical Device Fees for FY 2014

Fees Relating to Medical Device   Applications

Application Type

Standard Fee

Small Business

Premarket   Application (PMA, BLA, PDP)

$258,520

$64,630

Premarket   report (for a reprocessed single-use device)

$258,520

$64,630

Panel-track   PMA supplement

$193,890

$48,473

BLA   efficacy supplement

$258,520

$64,630

180-day   PMA supplement

$38,778

$9,695

Real-time   PMA supplement

$18,096

$4,524

510(k)   premarket notification

$5,170

$2,585

30-day   notice

$4,136

$2,068

513(g)   request for classification information

$3,490

$1,745

Annual fee for periodic reporting on a class III device

$9,048

$2,262

Establishment Registration Fee — There   is no reduced fee for a small business. If this is the only fee you   expect to pay during FY 2014, do not submit an FY 2014 Small Business   Qualification and Certification request.

Type of Fee

Annual Fee

Establishment   registration fee

$3,313

參考資料:

美國食品藥物管理局 http://www.fda.gov/

 

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