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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
All written comments should be identified with this document's docket number: FDA-2018-D-1774.
Q Global
Regulated Product(s)
Topic(s)
Q Bobby Pins And Lip Gloss Swatches
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)
Q Drops
- 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