Medical Devices: Current Good Manufacturing Practice (CGMP), Quality System (Q/S) Regulation; 21 CFR Part 820

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0073 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Medical Devices: Current Good Manufacturing Practice (CGMP), Quality System (Q/S) Regulation; 21 CFR Part 820	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Migrated

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 9,229	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1	-7,236	7,237
Annual IC Time Burden (Hours)	3,167,670	-735,499	3,903,169
Annual IC Cost Burden (Dollars)	1,182,000	-27,080,000	28,262,000

Documents for IC

Title	Document	Date Uploaded

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