Premarket Notification Submission 5100(k), Subpart E

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3514 CDRH Premarket Review Submission Cover Sheet	Form and Instruction	Modified	Available
Form 3654 Standard Data Report for 519 (K)s	Form and Instruction	Modified	Available
Form 3541 Premarket Notification [510 ( K )] Status Request and Response	Form and Instruction	Modified	Available
SS-0910-0120.DOC	Supporting Statement A	Uploaded 2007-05-17	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5734	Premarket Notification Submission 5100(k), Subpart E	Form and Instruction	Modified	CDRH Premarket Review Submission Cover Sheet
5734	Premarket Notification Submission 5100(k), Subpart E	Form and Instruction	Modified	Standard Data Report for 519 (K)s
5734	Premarket Notification Submission 5100(k), Subpart E	Form and Instruction	Modified	Premarket Notification [510 ( K )] Status Request and Response

ICR Details

OMB Control No: 0910-0120	ICR Reference No: 200705-0910-004
Status: Historical Active	Previous ICR Reference No: 200403-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Premarket Notification Submission 5100(k), Subpart E
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/27/2007
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/25/2007
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	08/31/2007
Responses	26,206	0	26,100
Time Burden (Hours)	303,528	0	359,000
Cost Burden (Dollars)	0	0	0

---

Abstract: This information collection requires a person who intends to market a medical device to submit premarket notification submission to FDA as least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. The information collected in a premarket notification allows for scientific and/or medical review of devices, subject to section 510(k) of the act, to confirm that the new devices are as safe and as effective as legally marketed predicate devices.

---

Authorizing Statute(s): US Code: 21 USC 510
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 64711	11/03/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 9005	02/28/2007
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Premarket Notification Submission 5100(k), Subpart E	3541, 3654, 3514	Premarket Notification [510 ( K )] Status Request and Response ,   Standard Data Report for 519 (K)s ,   CDRH Premarket Review Submission Cover Sheet

---

ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	26,206	26,100	0	0	106	0
Annual Time Burden (Hours)	303,528	359,000	0	0	-55,472	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated annual burden for this collection of information has decreased(adjustment). The number of 510 (K) submissions has been decreasing each year, and is projected to decrease further in the future due to FDAMA, MDUFMA, product reclassification efforts, and CDRH reengineering and strategic efforts. The burden has changed due to the decrease in the number of submissions received from respondents as more 510 (K ) device exemptions have been granted. FDA now estimates that it will receive about 3,700 510 (K) submissions per year. The total estimated burden hours for completion of a premarket notification have therefore been reduced. The burden for this collection has decreased by 55,472 hours due to the reduction in the number of premarket notifications expected in a year. In addition, there was an adjustment made to correct an error in which 21 CFR 807.93 was incorrectly identified as a recordkeeping requirement but has been correctly changed to a reporting requirement. This change (adjustment) did not result in a change to the original burden estimate. This action was discussed and confirmed in discussions with Seleda Perryman, HHS Reports Clearance Officer.

---

Annual Cost to Federal Government: $20,009

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/25/2007

---