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`CFR - Code of Federal Regulations Title 21
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`CFR - Code of Federal Regulations Title 21
`The information on this page is current as of April 1 2015.
`For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations
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`[Code of Federal Regulations]
`[Title 21, Volume 5]
`[Revised as of April 1, 2015]
`[CITE: 21CFR314.94]
`
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`TITLE 21--FOOD AND DRUGS
`CHAPTER I--FOOD AND DRUG ADMINISTRATION
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`SUBCHAPTER D--DRUGS FOR HUMAN USE
`PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
`Subpart C--Abbreviated Applications
`Sec. 314.94 Content and format of an abbreviated application.
`Abbreviated applications are required to be submitted in the form and
`contain the information required under this section. Three copies of
`the application are required, an archival copy, a review copy, and a
`field copy. FDA will maintain guidance documents on the format and
`content of applications to assist applicants in their preparation.
`(a) Abbreviated new drug applications. Except as provided in paragraph
`(b) of this section, the applicant shall submit a complete archival
`copy of the abbreviated new drug application that includes the
`following:
`(1) Application form. The applicant shall submit a completed and
`signed application form that contains the information described under
`314.50(a)(1), (a)(3), (a)(4), and (a)(5). The applicant shall state
`whether the submission is an abbreviated application under this
`section or a supplement to an abbreviated application under 314.97.
`(2) Table of contents. the archival copy of the abbreviated new drug
`application is required to contain a table of contents that shows the
`volume number and page number of the contents of the submission.
`(3) Basis for abbreviated new drug application submission. An
`abbreviated new drug application must refer to a listed drug.
`Ordinarily, that listed drug will be the drug product selected by the
`agency as the reference standard for conducting bioequivalence
`testing. The application shall contain:
`(i) The name of the reference listed drug, including its dosage form
`and strength. For an abbreviated new drug application based on an
`approverd petition under 10.30 of this chapter or 314.93, the
`reference listed drug must be the same as the listed drug approved in
`the petition.
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`(ii) A statement as to whether, according to the information published
`in the list, the reference listed drug is entitled to a period of
`marketing exclusivity under section 505(j)(4)(D) of the act.
`(iii) For an abbreviated new drug application based on an approved
`petition under 10.30 of this chapter or 314.93, a reference to FDA-
`assigned docket number for the petition and a copy of FDA's
`correspondence approving the petition.
`(4) Conditions of use. (i) A statement that the conditions of use
`prescribed, recommended, or suggested in the labeling proposed for the
`drug product have been previously approved for the reference listed
`drug.
`(ii) A reference to the applicant's annotated proposed labeling and to
`the currently approved labeling for the reference listed drug provided
`under paragraph (a)(8) of this section.
`(5) Active ingredients. (i) For a single-active-ingredient drug
`product, information to show that the active ingredient is the same as
`that of the reference single-active-ingredient listed drug, as
`follows:
`(A) A statement that the active ingredient of the proposed drug
`product is the same as that of the reference listed drug.
`(B) A reference to the applicant's annotated proposed labeling and to
`the currently approved labeling for the reference listed drug provided
`under paragraph (a)(8) of this section.
`(ii) For a combination drug product, information to show that the
`active ingredients are the same as those of the reference listed drug
`except for any different active ingredient that has been the subject
`of an approved petition, as follows:
`(A) A statement that the active ingredients of the proposed drug
`product are the same as those of the reference listed drug, or if one
`of the active ingredients differs from one of the active ingredients
`of the reference listed drug and the abbreviated application is
`submitted under the approval of a petition under 314.93 to vary such
`active ingredient, information to show that the other active
`ingredients of the drug product are the same as the other active
`ingredients of the reference listed drug, information to show that the
`different active ingredient is an active ingredient of another listed
`drug or of a drug that does not meet the definition of "new drug" in
`section 201(p) of the act, and such other information about the
`different active ingredient that FDA may require.
`(B) A reference to the applicant's annotated proposed labeling and to
`the currently approved labeling for the reference listed drug provided
`under paragraph (a)(8) of this section.
`(6) Route of administration, dosage form, and strength. (i)
`Information to show that the route of administration, dosage form, and
`strength of the drug product are the same as those of the reference
`listed drug except for any differences that have been the subject of
`an approved petition, as follows:
`(A) A statement that the route of administration, dosage form, and
`strength of the proposed drug product are the same as those of the
`reference listed drug.
`(B) A reference to the applicant's annotated proposed labeling and to
`the currently approved labeling for the reference listed drug provided
`under paragraph (a)(8) of this section.
`(ii) If the route of administration, dosage form, or strength of the
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`drug product differs from the reference listed drug and the
`abbreviated application is submitted under an approved petition under
`314.93, such information about the different route of administration,
`dosage form, or strength that FDA may require.
`(7) Bioequivalence. (i) Information that shows that the drug product
`is bioequivalent to the reference listed drug upon which the applicant
`relies. A complete study report must be submitted for the
`bioequivalence study upon which the applicant relies for approval. For
`all other bioequivalence studies conducted on the same drug product
`formulation as defined in 320.1(g) of this chapter, the applicant must
`submit either a complete or summary report. If a summary report of a
`bioequivalence study is submitted and FDA determines that there may be
`bioequivalence issues or concerns with the product, FDA may require
`that the applicant submit a complete report of the bioequivalence
`study to FDA; or
`(ii) If the abbreviated new drug application is submitted under a
`petition approved under 314.93, the results of any bioavailability of
`bioequivalence testing required by the agency, or any other
`information required by the agency to show that the active ingredients
`of the proposed drug product are of the same pharmacological or
`therapeutic class as those in the reference listed drug and that the
`proposed drug product can be expected to have the same therapeutic
`effect as the reference listed drug. If the proposed drug product
`contains a different active ingredient than the reference listed drug,
`FDA will consider the proposed drug product to have the same
`therapeutic effect as the reference listed drug if the applicant
`provides information demonstrating that:
`(A) There is an adequate scientific basis for determining that
`substitution of the specific proposed dose of the different active
`ingredient for the dose of the member of the same pharmacological or
`therapeutic class in the reference listed drug will yield a resulting
`drug product whose safety and effectiveness have not been adversely
`affected.
`(B) The unchanged active ingredients in the proposed drug product are
`bioequivalent to those in the reference listed drug.
`(C) The different active ingredient in the proposed drug product is
`bioequivalent to an approved dosage form containing that ingredient
`and approved for the same indication as the proposed drug product or
`is bioequivalent to a drug product offered for that indication which
`does not meet the definition of "new drug" under section 201(p) of the
`act.
`(iii) For each in vivo bioequivalence study contained in the
`abbreviated new drug application, a description of the analytical and
`statistical methods used in each study and a statement with respect to
`each study that it either was conducted in compliance with the
`institutional review board regulations in part 56 of this chapter, or
`was not subject to the regulations under 56.104 or 56.105 of this
`chapter and that each study was conducted in compliance with the
`informed consent regulations in part 50 of this chapter.
`(8) Labeling --(i) Listed drug labeling. A copy of the currently
`approved labeling (including, if applicable, any Medication Guide
`required under part 208 of this chapter) for the listed drug referred
`to in the abbreviated new drug application, if the abbreviated new
`drug application relies on a reference listed drug.
`(ii) Copies of proposed labeling. Copies of the label and all labeling
`for the drug product including, if applicable, any Medication Guide
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`required under part 208 of this chapter (4 copies of draft labeling or
`12 copies of final printed labeling).
`(iii) Statement on proposed labeling. A statement that the applicant's
`proposed labeling including, if applicable, any Medication Guide
`required under part 208 of this chapter is the same as the labeling of
`the reference listed drug except for differences annotated and
`explained under paragraph (a)(8)(iv) of this section.
`(iv) Comparison of approved and proposed labeling. A side-by-side
`comparison of the applicant's proposed labeling including, if
`applicable, any Medication Guide required under part 208 of this
`chapter with the approved labeling for the reference listed drug with
`all differences annotated and explained. Labeling (including the
`container label, package insert, and, if applicable, Medication Guide)
`proposed for the drug product must be the same as the labeling
`approved for the reference listed drug, except for changes required
`because of differences approved under a petition filed under 314.93 or
`because the drug product and the reference listed drug are produced or
`distributed by different manufacturers. Such differences between the
`applicant's proposed labeling and labeling approved for the reference
`listed drug may include differences in expiration date, formulation,
`bioavailability, or pharmacokinetics, labeling revisions made to
`comply with current FDA labeling guidelines or other guidance, or
`omission of an indication or other aspect of labeling protected by
`patent or accorded exclusivity under section 505(j)(5)(F) of the act.
`(9) Chemistry, manufacturing, and controls. (i) The information
`required under 314.50(d)(1), except that 314.50(d)(1)(ii)(c ) shall
`contain the proposed or actual master production record, including a
`description of the equipment, to be used for the manufacture of a
`commercial lot of the drug product.
`(ii) Inactive ingredients. Unless otherwise stated in paragraphs (a)
`(9)(iii) through (a)(9)(v) of this section, an applicant shall
`identify and characterize the inactive ingredients in the proposed
`drug product and provide information demonstrating that such inactive
`ingredients do not affect the safety or efficacy of the proposed drug
`product.
`(iii) Inactive ingredient changes permitted in drug products intended
`for parenteral use. Generally, a drug product intended for parenteral
`use shall contain the same inactive ingredients and in the same
`concentration as the reference listed drug identified by the applicant
`under paragraph (a)(3) of this section. However, an applicant may seek
`approval of a drug product that differs from the reference listed drug
`in preservative, buffer, or antioxidant provided that the applicant
`identifies and characterizes the differences and provides information
`demonstrating that the differences do not affect the safety or
`efficacy of the proposed drug product.
`(iv) Inactive ingredient changes permitted in drug products intended
`for ophthalmic or otic use. Generally, a drug product intended for
`ophthalmic or otic use shall contain the same inactive ingredients and
`in the same concentration as the reference listed drug identified by
`the applicant under paragraph (a)(3) of this section. However, an
`applicant may seek approval of a drug product that differs from the
`reference listed drug in preservative, buffer, substance to adjust
`tonicity, or thickening agent provided that the applicant identifies
`and characterizes the differences and provides information
`demonstrating that the differences do not affect the safety or
`efficacy of the proposed drug product, except that, in a product
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`intended for ophthalmic use, an applicant may not change a buffer or
`substance to adjust tonicity for the purpose of claiming a therapeutic
`advantage over or difference from the listed drug, e.g., by using a
`balanced salt solution as a diluent as opposed to an isotonic saline
`solution, or by making a significant change in the pH or other change
`that may raise questions of irritability.
`(v) Inactive ingredient changes permitted in drug products intended
`for topical use. Generally, a drug product intended for topical use,
`solutions for aerosolization or nebulization, and nasal solutions
`shall contain the same inactive ingredients as the reference listed
`drug identified by the applicant under paragraph (a)(3) of this
`section. However, an abbreviated application may include different
`inactive ingredients provided that the applicant identifies and
`characterizes the differences and provides information demonstrating
`that the differences do not affect the safety or efficacy of the
`proposed drug product.
`(10) Samples. The information required under 314.50(e)(1) and (e)(2)
`(i). Samples need not be submitted until requested by FDA.
`(11) Other. The information required under 314.50(g).
`(12) Patent certification --(i) Patents claiming drug, drug product,
`or method of use. (A) Except as provided in paragraph (a)(12)(iv) of
`this section, a certification with respect to each patent issued by
`the United States Patent and Trademark Office that, in the opinion of
`the applicant and to the best of its knowledge, claims the reference
`listed drug or that claims a use of such listed drug for which the
`applicant is seeking approval under section 505(j) of the act and for
`which information is required to be filed under section 505(b) and (c)
`of the act and 314.53. For each such patent, the applicant shall
`provide the patent number and certify, in its opinion and to the best
`of its knowledge, one of the following circumstances:
`(1 ) That the patent information has not been submitted to FDA. The
`applicant shall entitle such a certification "Paragraph I
`Certification";
`(2 ) That the patent has expired. The applicant shall entitle such a
`certification "Paragraph II Certification";
`(3 ) The date on which the patent will expire. The applicant shall
`entitle such a certification "Paragraph III Certification"; or
`(4 ) That the patent is invalid, unenforceable, or will not be
`infringed by the manufacture, use, or sale of the drug product for
`which the abbreviated application is submitted. The applicant shall
`entitle such a certification "Paragraph IV Certification". This
`certification shall be submitted in the following form:
`I, (name of applicant ), certify that Patent No. ______ (is invalid,
`unenforceable, or will not be infringed by the manufacture, use, or
`sale of ) (name of proposed drug product ) for which this application
`is submitted.
`The certification shall be accompanied by a statement that the
`applicant will comply with the requirements under 314.95(a) with
`respect to providing a notice to each owner of the patent or their
`representatives and to the holder of the approved application for the
`listed drug, and with the requirements under 314.95(c) with respect to
`the content of the notice.
`(B) If the abbreviated new drug application refers to a listed drug
`that is itself a licensed generic product of a patented drug first
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`approved under section 505(b) of the act, the appropriate patent
`certification under paragraph (a)(12)(i) of this section with respect
`to each patent that claims the first-approved patented drug or that
`claims a use for such drug.
`(ii) No relevant patents. If, in the opinion of the applicant and to
`the best of its knowledge, there are no patents described in paragraph
`(a)(12)(i) of this section, a certification in the following form:
`In the opinion and to the best knowledge of (name of applicant ),
`there are no patents that claim the listed drug referred to in this
`application or that claim a use of the listed drug.
`(iii) Method of use patent. (A) If patent information is submitted
`under section 505(b) or (c) of the act and 314.53 for a patent
`claiming a method of using the listed drug, and the labeling for the
`drug product for which the applicant is seeking approval does not
`include any indications that are covered by the use patent, a
`statement explaining that the method of use patent does not claim any
`of the proposed indications.
`(B) If the labeling of the drug product for which the applicant is
`seeking approval includes an indication that, according to the patent
`information submitted under section 505(b) or (c) of the act and
`314.53 or in the opinion of the applicant, is claimed by a use patent,
`an applicable certification under paragraph (a)(12)(i) of this
`section.
`(iv) Method of manufacturing patent. An applicant is not required to
`make a certification with respect to any patent that claims only a
`method of manufacturing the listed drug.
`(v) Licensing agreements. If the abbreviated new drug application is
`for a drug or method of using a drug claimed by a patent and the
`applicant has a licensing agreement with the patent owner, a
`certification under paragraph (a)(12)(i)(A)(4 ) of this section
`("Paragraph IV Certification") as to that patent and a statement that
`it has been granted a patent license.
`(vi) Late submission of patent information. If a patent on the listed
`drug is issued and the holder of the approved application for the
`listed drug does not submit the required information on the patent
`within 30 days of issuance of the patent, an applicant who submitted
`an abbreviated new drug application for that drug that contained an
`appropriate patent certification before the submission of the patent
`information is not required to submit an amended certification. An
`applicant whose abbreviated new drug application is submitted after a
`late submission of patent information, or whose pending abbreviated
`application was previously submitted but did not contain an
`appropriate patent certification at the time of the patent submission,
`shall submit a certification under paragraph (a)(12)(i) of this
`section or a statement under paragraph (a)(12)(iii) of this section as
`to that patent.
`(vii) Disputed patent information. If an applicant disputes the
`accuracy or relevance of patent information submitted to FDA, the
`applicant may seek a confirmation of the correctness of the patent
`information in accordance with the procedures under 314.53(f). Unless
`the patent information is withdrawn or changed, the applicant shall
`submit an appropriate certification for each relevant patent.
`(viii) Amended certifications. A certification submitted under
`paragraphs (a)(12)(i) through (a)(12)(iii) of this section may be
`amended at any time before the effective date of the approval of the
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`application. However, an applicant who has submitted a paragraph IV
`patent certification may not change it to a paragraph III
`certification if a patent infringement suit has been filed against
`another paragraph IV applicant unless the agency has determined that
`no applicant is entitled to 180-day exclusivity or the patent expires
`before the lawsuit is resolved or expires after the suit is resolved
`but before the end of the 180-day exclusivity period. If an applicant
`with a pending application voluntarily makes a patent certification
`for an untimely filed patent, the applicant may withdraw the patent
`certification for the untimely filed patent. An applicant shall submit
`an amended certification by letter or as an amendment to a pending
`application or by letter to an approved application. Once an amendment
`or letter is submitted, the application will no longer be considered
`to contain the prior certification.
`(A) After finding of infringement. An applicant who has submitted a
`certification under paragraph (a)(12)(i)(A)(4 ) of this section and is
`sued for patent infringement within 45 days of the receipt of notice
`sent under 314.95 shall amend the certification if a final judgment in
`the action against the applicant is entered finding the patent to be
`infringed. In the amended certification, the applicant shall certify
`under paragraph (a)(12)(i)(A)(3 ) of this section that the patent will
`expire on a specific date. Once an amendment or letter for the change
`has been submitted, the application will no longer be considered to be
`one containing a certification under paragraph (a)(12)(i)(A)(4 ) of
`this section. If a final judgment finds the patent to be invalid and
`infringed, an amended certification is not required.
`(B) After removal of a patent from the list. If a patent is removed
`from the list, any applicant with a pending application (including a
`tentatively approved application with a delayed effective date) who
`has made a certification with respect to such patent shall amend its
`certification. The applicant shall certify under paragraph (a)(12)(ii)
`of this section that no patents described in paragraph (a)(12)(i) of
`this section claim the drug or, if other relevant patents claim the
`drug, shall amend the certification to refer only to those relevant
`patents. In the amendment, the applicant shall state the reason for
`the change in certification (that the patent is or has been removed
`from the list). A patent that is the subject of a lawsuit under
`314.107(c) shall not be removed from the list until FDA determines
`either that no delay in effective dates of approval is required under
`that section as a result of the lawsuit, that the patent has expired,
`or that any such period of delay in effective dates of approval is
`ended. An applicant shall submit an amended certification. Once an
`amendment or letter for the change has been submitted, the application
`will no longer be considered to be one containing a certification
`under paragraph (a)(12)(i)(A)(4) of this section.
`(C) Other amendments. (1 ) Except as provided in paragraphs (a)(12)
`(vi) and (a)(12)(viii)(C)(2 ) of this section, an applicant shall
`amend a submitted certification if, at any time before the effective
`date of the approval of the application, the applicant learns that the
`submitted certification is no longer accurate.
`(2 ) An applicant is not required to amend a submitted certification
`when information on a patent on the listed drug is submitted after the
`effective date of approval of the abbreviated application.
`(13) Financial certification or disclosure statement. An abbreviated
`application shall contain a financial certification or disclosure
`statement as required by part 54 of this chapter.
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`(b) Drug products subject to the Drug Efficacy Study Implementation
`(DESI) review. If the abbreviated new drug application is for a
`duplicate of a drug product that is subject to FDA's DESI review (a
`review of drug products approved as safe between 1938 and 1962) or
`other DESI-like review and the drug product evaluated in the review is
`a listed drug, the applicant shall comply with the provisions of
`paragraph (a) of this section.
`(c) [Reserved]
`(d) Format of an abbreviated application. (1) The applicant must
`submit a complete archival copy of the abbreviated application as
`required under paragraphs (a) and (c) of this section. FDA will
`maintain the archival copy during the review of the application to
`permit individual reviewers to refer to information that is not
`contained in their particular technical sections of the application,
`to give other agency personnel access to the application for official
`business, and to maintain in one place a complete copy of the
`application.
`(i) Format of submission. An applicant may submit portions of the
`archival copy of the abbreviated application in any form that the
`applicant and FDA agree is acceptable, except as provided in paragraph
`(d)(1)(ii) of this section.
`(ii) Labeling. The content of labeling required under 201.100(d)(3) of
`this chapter (commonly referred to as the package insert or
`professional labeling), including all text, tables, and figures, must
`be submitted to the agency in electronic format as described in
`paragraph (d)(1)(iii) of this section. This requirement applies to the
`content of labeling for the proposed drug product only and is in
`addition to the requirements of paragraph (a)(8)(ii) of this section
`that copies of the formatted label and all proposed labeling be
`submitted. Submissions under this paragraph must be made in accordance
`with part 11 of this chapter, except for the requirements of 11.10(a),
`(c) through (h), and (k), and the corresponding requirements of 11.30.
`(iii) Electronic format submissions. Electronic format submissions
`must be in a form that FDA can process, review, and archive. FDA will
`periodically issue guidance on how to provide the electronic
`submission (e.g., method of transmission, media, file formats,
`preparation and organization of files).
`(2) For abbreviated new drug applications, the applicant shall submit
`a review copy of the abbreviated application that contains two
`separate sections. One section shall contain the information described
`under paragraphs (a)(2) through (a)(6), (a)(8), and (a)(9) of this
`section 505(j)(2)(A)(vii) of the act and one copy of the analytical
`procedures and descriptive information needed by FDA's laboratories to
`perform tests on samples of the proposed drug product and to validate
`the applicant's analytical procedures. The other section shall contain
`the information described under paragraphs (a)(3), (a)(7), and (a)(8)
`of this section. Each of the sections in the review copy is required
`to contain a copy of the application form described under 314.50(a).
`(3) [Reserved]
`(4) The applicant may obtain from FDA sufficient folders to bind the
`archival, the review, and the field copies of the abbreviated
`application.
`(5) The applicant shall submit a field copy of the abbreviated
`application that contains the technical section described in paragraph
`(a)(9) of this section, a copy of the application form required under
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`paragraph (a)(1) of this section, and a certification that the field
`copy is a true copy of the technical section described in paragraph
`(a)(9) of this section contained in the archival and review copies of
`the abbreviated application.
`[57 FR 17983, Apr. 28, 1992; 57 FR 29353, July 1, 1992, as amended at
`58 FR 47352, Sept. 8, 1993; 59 FR 50364, Oct. 3, 1994; 63 FR 5252,
`Feb. 2, 1998; 63 FR 66399, Dec. 1, 1998; 64 FR 401, Jan. 5, 1999; 65
`FR 56479, Sept. 19, 2000; 67 FR 77672, Dec. 19, 2002; 68 FR 69019,
`Dec. 11, 2003; 69 FR 18766, Apr. 8, 2004; 74 FR 2861, Jan. 16, 2009;
`76 FR 13880, Mar. 15, 2011]
`
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`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/MedicalDevices/default.htm
`5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
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`http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.94
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`10/28/2015
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`CFR - Code of Federal Regulations Title 21
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`6. http://www.ecfr.gov/cgi-bin/text-idx?
`SID=3ee286332416f26a91d9e6d786a604ab&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl
`7. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true
`8. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm
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`http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.94
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