Information Collection

Reporting; Voluntary Malfunction Summary Reporting Program

IC 231473 under ICR 202412-0910-004 · OMB 0910-0437.

Documents and Forms

Document Name Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting; Voluntary Malfunction Summary Reporting Program	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 4 21 CFR 803

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-FDA notification and order, "Medical Devices and Device-led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers"					Yes	Yes	Fillable Fileable
Other-Agency Guidance, "Voluntary Malfunction Summary Reporting Prgram for Manufacturers"					Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 44	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	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	2,503	-44,072	46,575
Annual IC Time Burden (Hours)	250	-4,408	4,658
Annual IC Cost Burden (Dollars)	0	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.