23-04-2021

Q & Abobby Pins And Lip Gloss



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Docket Number:
FDA-2018-D-1774

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Issued by:
Center for Biologics Evaluation and Research

The purpose of this guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the Food and Drug Administration (FDA) regarding potential or planned medical device Investigational Device Exemption (IDE) applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act).

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

Abobby

All written comments should be identified with this document's docket number: FDA-2018-D-1774.

Q Global

  • Regulated Product(s)

    Topic(s)


QTranslate is a free translator for Windows. With this small utility, you simply select the text you want to translate and then press the hot key ( Ctrl+Q to show translation in the popup window or Double Ctrl click to show the translation in the main window). QTranslate also has the ability to speak text Ctrl+E and perform a dictionary search Ctrl+Shift+Q . Also, you can open the main window and type text manually.

Note! QTranslate translates text by using online translation services, so you need an Internet connection.

The following translation services are supported:

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There are three modes of translation by mouse selection:
  • Show icon (select text in a program -> QTranslate icon will appear near cursor. Click the icon -> popup window with the translation of selected text will appear)
  • Show translation (select text in a program -> popup window with translation of the selected text will appear immediately)
  • Show translation and read (the same as previous plus speaking aloud selected text)
The main features:

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  • Text translation in any application that supports text selection
  • Speech recognition
  • Image text recognition (OCR API provided by OCR.SPACE)
  • Text to speech synthesis
  • Search in online dictionaries
  • Search in offline XDXF dictionaries
  • Spell checking
  • Word suggestion/autocomplete
  • History of translations
  • Virtual keyboard