Information Collection

Medical Device Development Tools (MDDT)

IC 275472 under ICR 202505-0910-013 · OMB 0910-0756.

Documents and Forms

Document Name Document Type
Guidance; Qualification of Medical Device Development Tools (MDDT).pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools Other-Guidance; Qualification of Med

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Medical Device Development Tools (MDDT)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance; Qualification of Medical Device Development Tools			Guidance; Qualification of Medical Device Development Tools (MDDT).pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/qualification-medical-device-development-tools	Yes	No	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 50	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	50	50
Annual IC Time Burden (Hours)	6,850	6,850
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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