Premarket Approval of Medical Devices - 21 CFR Part 814

Forms and Documents

Document Name	Status
eCopy Guidance.doc Supplementary Document	2012-12-12
eCopy 83c 0910-0231 12-12-12.doc Justification for No Material/Nonsubstantive Change	2012-12-12

IC Document Collections

IC ID	Document Title	Status
5826	Premarket Approval of Medical Devices - 21 CFR Part 814	Modified

ICR Details

OMB Control No: 0910-0231	ICR Reference No: 201212-0910-006
Status: Historical Active	Previous ICR Reference No: 201010-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Premarket Approval of Medical Devices - 21 CFR Part 814
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/19/2012
	Date Received in OIRA: 12/12/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	12/31/2013	12/31/2013
Responses	2,050	0	2,050
Time Burden (Hours)	100,870	0	100,870
Cost Burden (Dollars)	0	0	0

---

Abstract: The implementing regulations, contained in 21 CFR Part 814, specify the contents of a PMA for a medical device and the criteria FDA will employ in approving, denying, or withdrawing approval of a PMA and supplements to PMA's. The regulation's purpose is to establish an efficient and through procedure for FDA's review of PMA's and supplements to PMA's for class III (premarket approval) medical devices. The regulations also ensure the disapproval of PMA's and supplements to PMA's for devices that have not been show to be safe and effective and that do not otherwise meet the statutory criteria for approval.

---

Authorizing Statute(s): US Code: 21 USC 205 Name of Law: null
   US Code: 21 USC 201 Name of Law: null
   US Code: 21 USC 202 Name of Law: null
   US Code: 21 USC 208 Name of Law: null
   US Code: 21 USC 209 Name of Law: null
  

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

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Premarket Approval of Medical Devices - 21 CFR Part 814

---

ICR Summary 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	2,050	2,050	0	0	0	0
Annual Time Burden (Hours)	100,870	100,870	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $31,116,600

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? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 12/12/2012

---