CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements

Accreditation Scheme for Conformity Assessment Program

Documents and Forms

Document Name Document Type
ASCA-Pilot-Guidance SEPT 2020.pdf Other-Agency Guidance
ASCA-Pilot-Guidance SEPT 2020.pdf Other-Agency Guidance
ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf Other-Agency Guidance
ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf Other-Agency Guidance
ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf Other-Agency Guidance
ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf Other-Agency Guidance
ASCA STR format.pdf Other-webform
ASCA STR format.pdf Other-webform
ASCA webform mockups.pdf Other-webform
ASCA webform mockups.pdf Other-webform

Information Collection (IC) Details

IC Title:	CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	ASCA-Pilot-Guidance SEPT 2020.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	ASCA-Pilot-Biocompatibility-Guidance SEPT 2020.pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	ASCA-Pilot-Standards-Safety-Guidance SEPT 2020.pdf	Yes	Yes	Fillable Fileable
Other-webform	ASCA STR format.pdf	Yes	Yes	Fillable Fileable
Other-webform	ASCA webform mockups.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 158	Number of Respondents for Small Entity: 75

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,039	94	1,945
Annual IC Time Burden (Hours)	10,362	-3,129	13,491
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.