Information Collection

Medical Devices; Exception from General Requirements for Informed Consent

IC 6309 under ICR 201707-0910-010 · OMB 0910-0586.

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:	Medical Devices; Exception from General Requirements for Informed Consent	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 50.23

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 300	Number of Respondents for Small Entity: 60

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

Percentage of Respondents Reporting Electronically: 98 %

	Approved	Previously Approved
Annual Number of Responses for this IC	1,350	1,350
Annual IC Time Burden (Hours)	1,463	1,463
Annual IC Cost Burden (Dollars)	200	200

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.