De Novo requests

De Novo Classification Process (Evaluation of Automatic Class III Designation)

Documents and Forms

Document Name Document Type
0844_De Novo Classification Process (Evaluation of Automatic Class III Designation).pdf Other-De Novo Classification Process
0844_Acceptance Review for De Novo Classification Requests.pdf Other-Acceptance Review for De Novo
0844_Electronic Submission Template for Medical Device De Novo Requests.pdf Other-Electronic Submission Template

Information Collection (IC) Details

IC Title:	De Novo requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 860.210 21 CFR 860.220

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-De Novo Classification Process (Evaluation of Automatic Class III Designation)	0844_De Novo Classification Process (Evaluation of Automatic Class III Designation).pdf	Yes	No	Printable Only
Other-Acceptance Review for De Novo Classification Requests	0844_Acceptance Review for De Novo Classification Requests.pdf	Yes	No	Printable Only
Other-Electronic Submission Template for Medical Device De Novo Requests	0844_Electronic Submission Template for Medical Device De Novo Requests.pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 79	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	79	11	68
Annual IC Time Burden (Hours)	14,378	2,002	12,376
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.