Information Collection

Premarket Notification Submissions

IC 5734 under ICR 202508-0910-002 · OMB 0910-0120.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3881 Indications for Use Premarket Notification Submissions	Form
Form FDA 3514 CDRH Premarket Review Submission Cover Sheet Premarket Notification Submissions	Form and Instruction
Form FDA 4062 electronic Submission Template and Resource (eSTAR) Premarket Notification Submissions	Form and Instruction
Form FDA 4078 IVD electronic Submission Template and Resource (eSTAR) Premarket Notification Submissions	Form and Instruction
Guidance_Recognition and Withdrawal of Voluntary Consensus Standards.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standard	Other-Guidance; Recognition and With
Guidance_Refuse to Accept Policy for 510(k)s.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks?utm_source=chatgpt.com	Other-Guidance; Refuse to Accept Pol
0120_ASCA STR format.docx	Other-eSTAR for summary test reports
Guidance_Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 - www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement	Other-Guidance; Transition Plan for
FDA 3881 Indications for Use Form FDA 3881_Indications for Use.log	Form
FDA 3514 CDRH Premarket Review Submission Cover Sheet Form FDA 3514_CDRH PREMARKET REVIEW SUBMISSION COVER SHEET.log	Form and Instruction
FDA 4062 electronic Submission Template and Resource (eSTAR) eSTAR (static) FDA 4062.pdf	Form and Instruction
FDA 4078 IVD electronic Submission Template and Resource (eSTAR) IVD eSTAR (static) FDA 4078.pdf	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Premarket Notification Submissions

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 807, subpart E (807.81-807.100 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3881		Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3514		Yes	Yes	Fillable Fileable
Form and Instruction	FDA 4062		Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA 4078		Yes	Yes	Fillable Fileable Signable
Other-Guidance; Recognition and Withdrawal of Voluntary Consensus Standards		https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards	Yes	No	Printable Only
Other-Guidance; Refuse to Accept Policy for 510(k)s		https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks?utm_source=chatgpt.com	Yes	Yes	Printable Only
Other-eSTAR for summary test reports and data elements			Yes	Yes	Fillable Fileable Signable
Other-Guidance; Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency		https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policies-issued-during-coronavirus-disease	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 16,295

Number of Respondents for Small Entity: 1,050

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	16,295	3,625	12,670
Annual IC Time Burden (Hours)	469,183	145,804	323,379
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.

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