SUPPORTING STATEMENT

**PREMARKET NOTIFICATION SUBMISSION 510(K)**

**21 CFR PART 807, SUBPART E**

**OMB NO. 0910-0120**

# A. JUSTIFICATION

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 not determined to be 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]{.underline}**

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

**[21 CFR 807.81 - Reporting]{.underline}**

States when a premarket notification is required.

**[21 CFR 807.87 - Reporting]{.underline}**

Specifies information required in a premarket notification submission.

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 they are specifically
> exempted through the regulatory process. [Under 21 CFR
> 807.85]{.underline}, "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) 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]{.underline} 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, it's 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.

(i) 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:

(i) 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.

\(l\) 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.

**2. [Purpose and Use of the Information]{.underline}**

> The information collected in a premarket notification is used by the
> medical, scientific, and engineering staffs of FDA in making
> substantial equivalence determinations as to whether or not devices
> can 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.

3.  **[Use of Information Technology and Burden Reduction]{.underline}**

> There are no technical or legal obstacles to the collection of this
> information. The Center for Devices and Radiological Health (CDRH) has
> carefully studied the subject of electronic submittals of Premarket
> Notifications (510(k)s), and has concluded that electronic submittals
> would be helpful to the review process.
>
> CDRH is accepting medical device applications in electronic form. The
> Office of Device Evaluation (ODE) is 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 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.
>
> Until they are finalized, CDRH 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.
>
> An electronic version of the application should be submitted in a
> Portable Document Format (PDF) since the ODE staff will use Adobe
> Acrobat Exchange to review the PDF submission. This will assure that
> what a reviewer views on the screen is the same as what would have
> been seen on paper. Applications may be submitted on 3 diskettes or
> CD-ROM. If the application would require more than three diskettes,
> the preferred medium would be a CD-ROM.
>
> At the present time, CDRH only accepts the electronic 510(k)
> submission in forms such as a diskette or CD-ROM, and does not accept
> the submissions via an electronic form such as the internet world wide
> web at http://www.fda.gov/cdrh/elecsub.html. In FY 99 ODE received 8
> electronic 510(k) submissions and received 40 in FY 2000.

**4. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}**

> 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 Section 510(k) of the Act.

**5. [Impact on Small Businesses or Other Small Entities]{.underline}**

> FDA aids small business in dealing with the requirements of the
> regulations by providing guidance and information through the Division
> of Small Manufacturers Assistance, and through the scientific and
> administrative staff within the Center, and workshops in which the
> Center Staff participate. These efforts help to assure that the burden
> on all manufacturers, including small manufacturers, is minimized.

**6. [Consequences of Collecting the Information Less
Frequently]{.underline}**

> 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, that are as
> safe and effective as legally marketed predicate devices, are cleared
> for marketing.
>
> A premarket notification \[510(k)\] is a premarketing application
> submitted to FDA to demonstrate substantial equivalence to a legally
> marketed device currently on 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 devices for market.

**7. [Special Circumstances Relating to the Guidelines of 5 CFR
1320.5]{.underline}**

> This information collection is consistent with the guidelines
> prescribed in 5 CFR 1320.5.

**8. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside Agency]{.underline}**

> In accordance with 5 CFR 1320.8(d), on April 30, 2001 (66 FR 21398), a
> 60-day notice for public comment (Attachment 4 ) was published in the
> Federal Register. No comments were received from the public.
>
> The premarket notification program is one of the most scrutinized
> programs in FDA. During 1987-1988, the General Accounting Office (GAO)
> studied the premarket notification program; and during 1989-1990 the
> Inspector General's (IG's) Office of the DHHS did an in-depth review
> of the program. During 1992, the IG followed up their recommendations
> from 1990. Based on the reviews of both the GAO and IG, no major
> problems were identified with the premarket notification program
> related to those individuals/groups who are required to submit
> premarket notification applications. GAO did make two major
> recommendations for the premarket notification program:
>
> \(1\) to develop criteria for consistent review; and
>
> \(2\) to develop written documentation to detail the decision-making
> process.
>
> Both of these recommendations have been completed and implemented.
>
> The premarket notification program is constantly involved in on-going
> discussions, video conferences, and training with groups outside the
> agency including the following:
>
> AdVaMed
>
> 1200 G Street, NW
>
> Suite 400
>
> Washington, DC 20005
>
> \(202\) 783-8700
>
> Contact: Ms. Nancy Singer, Esq.
>
> Food and Drug Law Institute (FDLI)
>
> 1701 K Street, NW
>
> Suite 904
>
> Washington, DC 20006
>
> \(202\) 371-1420
>
> Contact: Mr. John Villforth, President
>
> Regulatory Affairs Professional Society (RAPS)
>
> 11300 Rockville Pike
>
> Suite 1000
>
> Rockville, MD 20852
>
> \(301\) 770-2920
>
> Contact: Ms. Linda Temple
>
> National Electrical Manufacturers Association (NEMA)
>
> 1300 North 17^th^ Street
>
> Suite 1847
>
> Rosslyn, VA 22209
>
> \(703\) 841-3200
>
> Contact: Mr. Robert Britain
>
> Medical Device Manufacturers Association (MDMA)
>
> 1900 K. Street, NW
>
> Suite 300
>
> Washington, D.C. 20006
>
> \(202\) 496-7150
>
> Contact: Stephen Northrup
>
> Orange County Regulatory Affairs Discussion Group
>
> PMB 624
>
> 5405 Alton Parkway 5A
>
> Irvine, CA 92604-3718
>
> \(949\) 348-9141
>
> New England Biomedical Discussion Group
>
> P.O. Box 1282
>
> Attleboro Falls, MA 02763-0282
>
> \(508\) 888-3324
>
> Contact: Mr. David Leo
>
> 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]{.underline}**

> There is no decision to provide any payment or gift to respondents.

**10. [Assurance of Confidentiality Provided to
Respondent]{.underline}**

> Confidentiality of information submitted to FDA under a premarket
> notification is governed by the provisions of [21 CFR
> 807.95]{.underline}, 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 once a device has been cleared for marketing. These provisions do
> not permit disclosure of information in a premarket notification
> submission that is made trade secret or commercial confidential unless
> that information has been previously disclosed or as permitted under
> the Federal Freedom of Information Act.

**11. [Justification for Sensitive Questions]{.underline}**

> 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 Hour Burden Including Annualized Hourly
Costs]{.underline}**

> The total reporting cost to industry is estimated at \$8,000 per
> submission. Approximately 80 hours is required to complete a 510(k)
> package (exclusive of preparing clinical data, research, etc.) The
> average to industry per hour for this type of work is \$150. The
> estimated submission cost of \$8,000 multiplied by 4,000 submissions
> per year equals \$32,000,000, which is the aggregated industry
> reporting cost.
>
> Using FY 2000 data, the total estimated recordkeeping cost to industry
> is \$250,000. The estimated total numbers of 510(k)s which are
> distributed by firms, as required when they choose to provide a 510(k)
> statement under 21 CFR 807.93, annually is 20,000. Approximately 30
> minutes are needed to process a request for information, so the total
> annual hours expended is 10,000. An average salary for recordkeepers
> is \$25 per hour; therefore, the total number of hours (10,000)
> multiplied by the average salary (\$25) equals \$250,000. The total
> cost for both the reporting and recordkeeping burden is therefore
> estimated to be \$32,250,000.
>
> A summary form, FDA Form 3514 (Attachment 6), has been created to
> assist respondents in organizing 510(k) data for submission to FDA.
> This form also assists respondents in organizing and submitting data
> for other FDA medical device programs such as PMA\'s, IDE\'s, HDE,
> etc.
>
> 21 CFR 807.81 - Reporting - and 21 CFR 807.87 - Reporting - 321,000
> burden hours
>
> 21 CFR 807.93 - Recordkeeping - 10,000 burden hours
>
> The total burden (1,000 hours) for FDA Form 3514 has been included in
> this information collection. Once this collection has been approved,
> the form will be referenced in the OMB information collections to
> which it is associated. These collections are OMB Numbers 0910-0078
> (IDE, 150 respondents and 75 hours), 0910-0231 (PMA, 40 regular
> respondents, 300 PMA supplement respondents, and 170 hours), 0910-0332
> (HDE, 10 respondents and 5 hours) and this collection , 0910-0120
> (510(k), 1,500 respondents and 750 hours). 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).
>
> 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. The definition of
> person/manufacturer has now been expanded to include hospitals who
> re-use or re-manufacture single use devices. The estimated 4,000
> submissions expected to be received by FDA includes those submitted by
> hospitals re-manufacturing single-use medical devices. Based on trends
> experienced in the past three (3) years, an estimated 4,000
> 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 80 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 notification, typing, and responding to
> any requests from FDA for supplemental information. FDA, therefore,
> estimates that a total of 331,000 hours of effort for reporting and
> recordkeeping are required for the 4,000 anticipated submissions.
>
> Since FY 2000, the Center has received an average of 4,200 original
> 510(k) submissions per year. That figure has been decreasing each
> year, and is projected to decrease further in the future due to FDAMA,
> 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. The total estimated burden hours for
> completion of a premarket notification have been therefore reduced.
>
> The estimate of burden for this collection of information is shown in
> the following tables:

Table 1.\--Estimated Annual Reporting Burden ^1^

  ----------- -------- ------------- ----------- ----------- ---------- --------- ---------
  21 CFR      Form     No. of        Annual      Total       Hours per            Total
  Section     Number   Respondents   Frequency   Annual      Response             Hours
                                     per         Responses                        
                                     Response                                     

  807 Subpart          4,000         1           4,000       80                   320,000
  E (807.81 &                                                                     
  807.87 -                                                                        
  510(k) )                                                                        

              FDA Form 2,000         1           2,000       0.5                  1,000
              3514                                                                

  TOTALS                                                                321,000   
  ----------- -------- ------------- ----------- ----------- ---------- --------- ---------

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

Table 2.\--Estimated Annual Recordkeeping Burden ^2^

  --------- -------- --------------- --------------- --------- -------------- -------- --------
  21 CFR    Form     No. of          Annual          Total     Hours per      Total    
  Section   Number   Recordkeepers   Frequency per   Annual    Recordkeeper   Hours    
                                     Recordkeeping   Records                           

  807.93             2,000           10              20,000    0.5            10,000   

  TOTALS                                                                               10,000
  --------- -------- --------------- --------------- --------- -------------- -------- --------

> ^2^ There are no capital costs or operating and maintenance costs
> associated with this collection of information.
>
> 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]{.underline}**

> There are no additional costs associated with this information
> collection.

**14. [Annualized Cost to the Federal Government]{.underline}**

> FDA estimates that a total of 185 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 \$92,296 per position (which is the agency's average cost of
> an FTE including their benefits), the estimated annual Federal cost is
> \$17,074,760.
>
> [FTEs Cost/FTE (incl Overhead) Total Cost]{.underline}
>
> 185 \$92,296 \$17,074,760

**15. [Explanation for Program Changes or Adjustments]{.underline}**

The burden to this collection has decreased by 79,000 hours due to a
decrease in the number of submissions received from respondents. The
decease in submissions has been attributed to an increased number of
510(k) device exemptions that have been granted by FDA.

**16. [Plans for Tabulation and Publication and Project Time
Schedule]{.underline}**

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

**17. [Reason(s) Display of OMB Expiration Date is
Inappropriate]{.underline}**

> Currently, CDRH is not requesting an exemption for display of the OMB
> expiration date.

**18. [Exception to Certification for Paperwork Reduction Act
Submissions]{.underline}**

> Currently, CDRH is not requesting an exemption to Certification for
> the Paperwork Reduction Act Submissions.

**B. [Collection of Information Employing Statistical
Methods]{.underline}**

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

**[List of Attachments to Supporting Statement:]{.underline}**

Attachment 1 - The Safe Medical Devices Act (SMDA) of 1990 (PL 101-629)

Attachment 2 - The Federal Food, Drug, and Cosmetic Act, Section 513

Attachment 3 - Code of Federal Regulations (21 CFR 807)

Attachment 4 - Federal Register 60 day Notice Soliciting Comments on
510(k) Submissions

Attachment 5 - FDAMA, Sections 510(l) and 510(m)

Attachment 6 - FDA Form 3514