0910-0120 ss 2010

Supporting Statement - OMB No. 0910-0120

SUPPORTING STATEMENT

PREMARKET NOTIFICATION

21 CFR PART 807, SUBPART E

OMB NO. 0910-0120

A. JUSTIFICATION

Abstract

Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) and the implementing regulation 21 CFR 807 Subpart E, require a person who intends to market a medical device to submit a premarket notification submission to the Food and Drug Administration at 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. Based on the information provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device, as defined in 21 CFR 807.92(a)(3). If the device is determined to be not substantially equivalent to a legally marketed device, it must have an approved premarket approval application (PMA), Product Development Protocol or be reclassified into Class I or Class II before being marketed. The FDA makes the final decision of whether a device is equivalent or not equivalent.

1. Circumstances Making the Collection of Information Necessary

The Food and Drug Administration (FDA) is requesting approval for the information collection requirements contained within 21 CFR 807 Subpart E. These requirements are:

21 807,87- Reporting

States when a premarket notification is required and what is required in the premarket notification submission.

21 CFR 807.92 – Reporting

Specifies information required in a premarket notification summary

21 CFR 807.93 – Reporting

Specifies content and format of a 510 (k) statement.

FDA is also requesting OMB approval for the following forms:

Form FDA 3514 “CDRH Premarket Review Submission Cover Sheet” http://inside.fda.gov:9003/downloads/Administrative/Forms/FDA/UCM026058.pdf

Form FDA 3541 “Premarket Notification [510(k)] Status Request and Response” http://inside.fda.gov:9003/downloads/Administrative/Forms/FDA/UCM014280.pdf

Form FDA 3654 “Standard Data Report for 510(k)s” http://inside.fda.gov:9003/downloads/Administrative/Forms/FDA/UCM012986.pdf

A premarket notification is required to be submitted by a person who is:

Introducing a device to the market for the first time;

Introducing or reintroducing a device which is significantly changed or modified in design, components, method of manufacturer, or the intended use that could affect the safety and effectiveness of the device.

Section 510(k) of the FD&C Act allows for exemptions to the 510(k) submissions, i.e., a premarket notification would not be required if the FDA determines that premarket notification is not necessary for the protection of the public health, and these are specifically exempted through the regulatory process. Additionally, under 21 CFR 807.85, “Exemption from premarket notification”, a device is exempt from premarket notification if the device intended for introduction into commercial distribution is not generally available in finished form for purchase and is not offered through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution, and the device meets one of the following conditions:

(1) It is intended for use by a patient named in order of the physician or dentist (or other specially qualified persons); or

(2) It is intended solely for use by a physician or dentist and is not generally available to other physicians or dentists.

A commercial distributor who places a device into commercial distribution for the first time under their own name and a repackager who places their own name on a device and does not change any other labeling or otherwise affect the device, shall be exempted from premarket notification if:

(1) The device was legally in commercial distribution before May 28, 1976; or

(2) A premarket notification was submitted by another person.

Additionally, the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Attachment 4) provided the authority for statutory exemption from the premarket notification requirements of the act in section 510(l) and 510(m). Section 510(l) states that a 510(k) is not required for any class I device with the exception of those that are intended for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury. Section 510(m) states that a class II device may be exempted from the 510(k) requirements of that act if a 510(k) is not necessary to provide reasonable assurance of safety and effectiveness.

21 CFR Section 807.87 on premarket notification lists the information required in each submission. Each premarket notification submission shall contain the following information:

(a) The device name, including both the trade or proprietary name and the common or usual name or classification name of the device.

(b) The establishment registration number, if applicable, of the owner or operator submitting the premarket notification submission.

(c) The class in which the device has been put under section 513 of the Act and, if known, its appropriate panel; or if the owner or operator determines that the device has not been classified under such section, a statement of the determination and the basis for the person’s determination that the device is not so classified.

(d) Action taken by the person required to comply with the requirements of the Act under section 514 for performance standards.

(e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings should be supplied.

(f) A statement indicating that the device is similar to and/or different from other products of a comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.

(g) Where a person required to register intends to introduce into commercial distribution a device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use, the premarket notification submission must include appropriate supporting data to show that the manufacturer has considered what consequences and effects that change or modification or new use might have on the safety and effectiveness of the device.

(h) A 510(k) summary as described in §807.92 or a 510(k) statement as described in §807.93.

1. A financial certification or disclosure statement or both, as required by part 54 of 21 Code of Federal Regulations.

(j) For submissions claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act:

1. Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990 and

(ii) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about class III device and other similar legally marketed devices has been conducted (class III certification), as described in  807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under Section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the class III summary or citation.

(k)A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

12. Any additional information regarding the device requested by the Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Commissioner to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least 90 days before the owner or operator intends to market the device or submit a premarket approval application in accordance with section 515 of the Act. If additional information is not submitted within 30 days following the date of the request, the Commissioner will consider the premarket notification to be withdrawn.

This information collection is not related to the American Recovery and Reinvestment Act of 2009.

2. Purpose and Use of the Information

The information collected in a premarket notification is used by the medical, scientific, regulatory and engineering staffs of FDA in making substantial equivalence determinations as to whether or not devices have been determined to provide reasonable assurance of the safety and effectiveness of the device in order to demonstrate substantial equivalence and can, therefore, be allowed to enter the U.S. market. If the information were not collected, the impact to the Federal program would be negligible. The impact, however, to the public health of the U.S. would be great. The premarket notification review process allows for scientific and/or medical review of devices, subject to 510(k) of the Act, to confirm that the new devices are as safe and as effective as legally marketed predicate devices. This review process, therefore, prevents potentially unsafe and/or ineffective devices, including those with fraudulent claims, from entering the U.S. market.

The respondents to this information collection are from the private sector; business or other for profit.

3. Use of Information Technology and Burden Reduction

In the Federal Register of March 20, 1997, FDA published a final rule establishing procedures for electronic records, electronic signatures, and electronic submissions. A sponsor, applicant or manufacturer may use the appropriate technology in accordance with this rule to comply with the requirements of the guidance.

CDRH is accepting medical device applications in electronic form. The Office of Device Evaluation (ODE) accepts an electronic copy and the Office of In Vitro Diagnostic Device Evaluation and Safety accepts electronic submissions. Both offices are currently developing formal guidelines regarding electronic submissions. Submission of electronic documents rather than paper will be voluntary on the part of manufacturers, and will also meet the requirements of Government Paper Elimination Act (GPEA) Reviewers will have ready access to the electronic submission for reading and review on their desktop computers. Reviewer notes will also be stored electronically directly, without the need to scan paper documents. In the interim, FDA has provided some informal guidance on electronic submissions, entitled “Electronic Copies for Premarket Submissions.” Until these electronic submissions are finalized, CDRH/ODE is requesting that industry give prior notification of their desire to submit an application in electronic form. This lead time is important in order to assure that the reviewer has the necessary hardware and software to review the electronic application so that the electronic submission will facilitate the review process.

It should be understood that an electronic application does not change the order in which submissions are reviewed. No preferential treatment will be given to manufacturers who submit an electronic application. In addition, at least one paper copy of the submission is also required. Additional copies of some reports may be requested in order to help facilitate the review.

FDA estimates that 40% of the respondents will use electronic means to fulfill the agency’s requirement.

4. Efforts to Identify Duplication and Use of Similar Information

FDA is the only agency responsible for the collection of this information, and there are no requirements for the submission of similar information. Therefore, no duplication of data exists. No data exists from any source, other than the premarket notification submitter, that can be used to provide FDA with information regarding safety and effectiveness of devices subject to this regulation. No other data can be used to monitor the introduction of the devices subject to the requirement to submit a 510(k) under Section 510(k) of the Act.

5. Impact on Small Businesses or Other Small Entities

FDA estimates that 1,550 respondents are considered small businesses.

The information collection will have a minimal impact on a substantial number of small entities. FDA also aids small business in dealing with the requirements of the regulations by providing guidance and information through the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA), and through the scientific and administrative staff, workshops in which FDA Staff participate, and through the CDRH website at http://www.fda.gov/cdrh . These efforts help to assure that the burden on all manufacturers, including small manufacturers, is minimized.

6. Consequences of Collecting the Information Less Frequently

Data relative to 510(k) premarket notification cannot be collected less frequently. The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act require that notification be submitted at least 90 days before a device intended for human use is introduced into commerce. Ensuring compliance with the Act would not be possible if data were collected less frequently.

The information collected in the premarket notification is necessary for FDA to ensure that only those submissions for devices subject to the 510(k) requirements of the Act, which are as safe and effective as legally marketed predicate devices, are cleared for marketing in the U.S.

A premarket notification [510(k)] is a premarketing application submitted to FDA to demonstrate substantial equivalence to a legally marketed device currently legally marketed in the U.S. market, which does not require premarket approval. The consequence of not obtaining this information would be that the FDA would not be able to provide a mechanism for clearing certain device types for market.

There are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.6

This information collection is consistent with the guidelines prescribed in 5 CFR 1320.6.

8. Efforts to Consult Outside Agency

In a Federal Register of May 5, 2010 (75 FR 24708), FDA published a 60 day notice soliciting comments on the information collection requirements. In response to that notice, no comments were received.

The premarket notification program is constantly involved in on-going discussions, video conferences, and training with groups outside the agency including the following:

AdvaMed

701 Pennsylvania Avenue, NW

Suite 800

Washington, DC  20004

(202) 434-7228

Contact:  Ms. Janet Trunzo, Executive Vice President, Technology and Regulatory Affairs

 

Food and Drug Law Institute (FDLI)

1155 15th Street, NW

Suite 800

Washington, DC  20005

(202) 371-1420

Contact: Ms. Susan C. Winckler, RPh, JD, President and CEO

 

 National Electrical Manufacturers Association (NEMA)

1300 North 17^th Street

Suite 1752

Rosslyn, VA 22209

(703) 841-3200

Contact:  Mr. Evan R. Gaddis, President & CEO

 

Medical Device Manufacturers Association (MDMA)

1350 I Street, NW

Suite 540

Washington, D.C.  20005

(202) 354-7171

Contact:  Mr. Mark B. Leahey, Esq., President & CEO

 

FDA has issued many guidance documents to assist manufacturers in preparing premarket notification submissions including many guidances that address preparing premarket notifications for specific types of devices. Under 21 CFR 10.115, FDA issues these guidances as drafts and invites comments when the guidance sets forth an initial interpretation of a statutory or regulatory requirement or when it includes changes that are of more than a minor nature. In addition, in section 10.115, FDA invites interested persons to submit comments at any time on an existing guidance, to suggest areas for guidance development, or to submit a draft guidance document to FDA for consideration. Following these procedures, FDA has used public input to review and revise existing guidance documents and to issue new guidance documents. The submitter of a premarket notification may choose an alternative to the recommendations of a guidance. FDA works with submitters to develop an alternative approach when appropriate.

Also, due to the premarket notification program’s regulatory nature, FDA is constantly in contact with the respondents during the review of their submissions.

9. Explanation of Any Payment or Gift to Respondents

No payment or gifts in any manner or form shall be provided to respondents under this regulation.

10. Assurance of Confidentiality Provided to Respondent

Confidentiality of information submitted to FDA under a premarket notification is governed by the provisions of 21 CFR Parts 20 and 807.95, and is mandated. However, the purpose of the 510(k) summaries or 510(k) statements submitted in a premarket notification is to make information available to the public within 30 days if a device has been cleared for marketing through the 510(k) process. These provisions do not permit disclosure of information in a premarket notification submission that is trade secret or commercial confidential unless that information has been previously disclosed or as permitted under the Federal Freedom of Information Act. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to government documents. Information provided under this collection is handled in a manner to comply with the FDA regulations on public information in 21 CFR Part 20 (Attachment 6).

11. Justification for Sensitive Questions

This information collection does not include questions pertaining to sexual behavior, attitude, religious beliefs, or any other matters that are commonly considered private or sensitive in nature.

12. Estimates of Annualized Burden and Costs

12a. Annualized Hour Burden Estimate

Any person/manufacturer who proposes to begin commercial distribution of a device, intended for human use, into interstate commerce is required to send a premarket notification submission to the FDA at least 90 days in advance of marketing. Based on trends experienced in the past three (3) years, an estimated 3,800, submissions are expected each year. FDA’s administrative and technical staff, who are familiar with the requirements for submission of premarket notifications, estimate that an average of 90 hours are required to prepare a submission. There is a variance in the preparation of the premarket notification submission because of the vast and varying complexities of medical devices. This includes preparation and writing of the typing, and responding to any requests from FDA for supplemental information.

FDA has created FDA Form 3514, a summary cover sheet form to assist respondents in categorizing 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs premarket approval applications (OMB No. 0910-0231), investigational device exemptions (OMB No. 0910-0078) and humanitarian device exemptions (OMB No. 0910-0332). The total burden (978 hours) for FDA Form 3514 has been included in this information collection. A reference in each of the OMB Information Collections mentioned above will indicate that the overall burden for this form has been recognized in this collection (OMB 0910-0120). Based on a number of reviews of the summary cover sheet during the past 2 years, FDA estimates that it will receive 1,956 summary cover sheets a year. Approximately 30 minutes are needed to complete the summary cover sheet.

FDA has created FDA Form 3541, to assist 510(k) submitters in requesting information on the status of the review of their 510(k) submission. Based on a review of the number of status requests in the past two years, FDA estimates that it will receive about 218 status requests in a year. The respondent must complete some basic identifying information about the 510(k) and then fax or mail it to FDA. FDA estimates that completing the form and mailing it to FDA will take about 15 minutes.

Section 204 of FDAMA amended section 514 of the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions including premarket notifications or other requirements. FDA has published and updated the list of recognized standards regularly since enactment of FDAMA and has allowed 510(k) submitters to certify conformance to recognized standards to meet the requirements of § 807.87. Certification of conformance to a recognized standard may allow a manufacturer to submit an Abbreviated 510(k). FDA has created FDA Form 3654 to standardize information submitted on the use of standards in support of a 510(k) submission. Previously, if a submitter chose to use standards in support of their 510(k) submission, they would only fill out the portions of the form they deemed necessary. However, the FDA is now requiring this form to be completed in full, should it be submitted with a 510(k) submission. Therefore the burden associated with completing this form has increased from one hour to ten hours. FDA believes that the use and full completion of this form will simplify the process for 510(k) submitters who choose to use standards in support of substantial equivalence, as well as the review and a complete documentation process for FDA. Based on a review of 510(k) notifications submitted in the last two fiscal years, FDA estimates that it will receive about 1,500 submissions a year and it will take 10 hours to complete this form.

Under 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) as required by 807.92 (510(k) summary) or a statement certifying that the submitter will make available upon request the information in the 510(k) with certain exceptions as per 807.93 (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the 510(k) submission, 807.93 requires that the official correspondent of the firm make available within 30 days of a request, all information included in the submitted premarket notification on safety and effectiveness. This information will be provided to any persons within 30 days of a request if the device described in the 510(k) is determined to be substantially equivalent. The information provided will be a duplicate of the 510(k) submission including and safety and effectiveness information, but excluding all patient identifiers and trade secret and commercial confidential information. Previously, the FDA allowed a submitter to only comply with portions of these requirements they deemed necessary. However, FDA is now requiring all submitters to fully comply with the requirements set forth in both sections 807.92 and 807.93. Therefore the burden per respondent has been increased from .05 hours to 10 hours per response.

The estimate of burden for this collection of information is shown in the following tables:

Table 1.--Estimated Annual Reporting Burden ¹

21 CFR Section	Form Number	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response		Total Hours
807 Subpart E		3,800	1	3,800	79		300,200
807.87	FDA Form 3514	1,956	1	1,956	0.5		978
807.90 (a)(3)	FDA Form 3541	218	1	218	0.25		55
807.87 (d) and (f)	FDA Form 3654	1,500	1	1,500	10		15,000
807. 92 and 807.93		2,000	10	2,000	10		20,000
TOTALS						336,233

¹ There are no capital costs or operating and maintenance costs associated with this collection of information.

12b. Annualized Cost Burden Estimate

The average to industry per hour for this type of work is $100. Therefore, FDA estimates the total reporting cost to industry for 510(k) submissions at $7,900 per submission. The estimated submission cost of $7,900 multiplied by 3,800 submissions per year equals $30,020,000.

FDA has based these estimates on conversations with industry and trade association representatives, and from internal review of the documents listed in the tables above.

13. Estimate of Other Total Annual Cost Burden to Respondents or Recordkeepers

There are no additional costs associated with this information collection

14. Annualized Cost to the Federal Government

FDA estimates that a total of 187 full time equivalent (FTE) positions consisting of a combination of medical officers, dental officers, scientific, and engineering professionals and support staff are required for premarket notification review and processing. Based on a cost of $142,200 per position (which is the agency’s average cost of an FTE including their benefits), the estimated annual Federal cost is $26,591,400.

FTEs Cost/FTE (incl Overhead) Total Cost

187 $142,200 $26,591,400.00

15. Explanation for Program Changes or Adjustments

FDA has re-estimated this collection of information, FDA now estimates that it will receive about 3,800 510(k) submissions per year. The total estimated burden hours for the completion of a premarket notification have been therefore increased. The burden hours for this collection have increased by 32,705 due to the increase in the number of premarket notifications expected in a year. The hours per response have increased, because previously the FDA allowed a submitter to only comply with portions of these requirements they deemed necessary. However, FDA is now requiring all submitters to fully comply with the requirements set forth in both sections 807.92 and 807.93. Additionally FDA is now requiring FDA form 3654 to be completed in full, should it be submitted with a 510(k) submission.

16. Plans for Tabulation and Publication and Project Time Schedule

FDA does not intend to publish or tabulate the results of this information collection.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

FDA is not requesting an exemption for display of the OMB expiration date.

18. Exception to Certification for Paperwork Reduction Act Submissions

FDA is not requesting an exemption to Certification for the Paperwork Reduction Act Submissions.

B. Collection of Information Employing Statistical Methods

There are no statistical methods being employed in this collection of information.

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