Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability, 101-102 [2012-31476]

Download as PDF Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices review. It was suggested that FDA identify a particular location within the submission for this information, noting that such information could be found in multiple locations. The guidance has been revised to suggest more specific locations within the submission where this information can be provided for the ease of compiling a 510(k) and to facilitate FDA staff’s acceptance review. Other comments provided editorial suggestions for clarity and for consistency with other FDA guidance documents. In response to these comments, FDA revised the guidance document to clarify the processes and policies as appropriate. This guidance supersedes the guidances ‘‘Center for Devices and Radiological Health’s Premarket Notification (510(k)) Refuse to Accept Policy’’ issued on June 30, 1993 and ‘‘510(k) Refuse to Accept Procedures, 510(k) Memorandum K94– 1’’ issued on May 20, 1994. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on the refuse to accept policy for 510(k)s. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. tkelley on DSK3SPTVN1PROD with III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive ‘‘Refuse to Accept Policy for 510(k)s,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1793 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, have been VerDate Mar<15>2010 16:42 Dec 31, 2012 Jkt 229001 approved under OMB control number 0910–0120. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to http:// www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: December 26, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–31477 Filed 12–31–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0524] Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).’’ The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document SUMMARY: PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 101 entitled ‘‘Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002; or Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993–0002, 301– 796–6570; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. I. Background The PMA regulation (21 CFR 814.42(e)) identifies the criteria that, if not met, may serve as a basis for refusing to file a PMA. These criteria are discussed in the guidance document ‘‘Guidance for Industry and FDA Staff Premarket Approval Application Filing Review,’’ dated May 1, 2003. This document has been used by FDA staff and the device industry to help elucidate the broad preclinical and clinical issues that need to be addressed in a PMA and the key decisions to be made during the filing process. The guidance entitled ‘‘Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)’’ supersedes the guidance entitled ‘‘Guidance for Industry and FDA Staff Premarket Approval Application Filing Review.’’ To further focus the Agency’s review resources on complete applications, which will provide a more efficient approach to ensuring that devices that have a reasonable assurance of safety E:\FR\FM\02JAN1.SGM 02JAN1 tkelley on DSK3SPTVN1PROD with 102 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices and effectiveness reach patients as quickly as possible, we have modified the PMA filing guidance. In this guidance entitled, ‘‘Acceptance and Filing Reviews for Premarket Approval Applications (PMAs),’’ we have separated the requirements for PMA filing into: (1) Acceptance criteria and (2) filing criteria. Acceptance review involves an early assessment of the completeness of the application, and informing the applicant in a written response within the first 15 calendar days of receipt of the application whether any administrative elements are missing, and if so, identifying the missing administrative element(s). In order to enhance the consistency of our acceptance and filing decisions and to help applicants understand the types of information FDA needs to conduct a substantive review of a PMA, this guidance and associated checklist clarify the necessary elements and contents of a complete PMA application. The process we outline is applicable to all devices reviewed in a PMA application. Acceptance and filing decisions will be made for all original PMA applications and panel-track PMA supplements. This guidance is not significantly different from the 2003 PMA guidance document. The ‘‘preliminary questions’’ remain the same and the ‘‘filing review questions’’ have been separated into ‘‘acceptance decision questions’’ (i.e., is the file administratively complete) and ‘‘filing decision questions’’ (i.e., are data consistent with protocol, final device design, and proposed indications). In addition, it should be noted that this document is focused on the regulatory and scientific criteria for making an ‘‘Accept’’ or ‘‘Refuse to Accept’’ decision as well as ‘‘File’’ or ‘‘Not File’’ decision for a PMA. It specifically does not alter the following administrative aspects of the PMA filing process: (1) The time frame for the filing review phase (i.e., 45 days); (2) the processes for document tracking, distribution, and handling; and (3) the procedures for assembling the review team and setting up the filing meeting. In the Federal Register of July 31, 2012 (77 FR 45357), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by September 14, 2012. Nine comments were received with multiple recommendations pertaining to the administrative processes and policies regarding acceptance and filing review decisions. In response to these comments, FDA revised the guidance document to clarify the processes and policies as appropriate. This guidance supersedes VerDate Mar<15>2010 21:57 Dec 31, 2012 Jkt 099060 the guidance entitled ‘‘Guidance for Industry and FDA Staff Premarket Approval Application Filing Review,’’ dated May 1, 2003. of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on acceptance and filing reviews for PMAs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. Dated: December 26, 2012. Leslie Kux, Assistant Commissioner for Policy. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from the CBER internet site at http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm. To receive ‘‘Acceptance and Filing Reviews for Premarket Approval Applications (PMAs),’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1792 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 814, subpart B, have been approved under OMB control number 0910–0231. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to http:// www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 [FR Doc. 2012–31476 Filed 12–31–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘eCopy Program for Medical Device Submissions.’’ The purpose of the guidance is to explain the new electronic copy (eCopy) Program for medical device submissions, which is intended to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. The guidance describes how FDA has implemented the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance also provides the standards for a valid eCopy under the FD&C Act and identifies the submission types that must include an eCopy in accordance with these standards for the submission to be processed and accepted for review by FDA. This final guidance will be considered in effect on January 1, 2013, or at the time of publication, whichever is later. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘eCopy Program for Medical Device Submissions’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002. Send SUMMARY: E:\FR\FM\02JAN1.SGM 02JAN1

Agencies

[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Notices]
[Pages 101-102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0524]


Guidance for Industry and Food and Drug Administration Staff; 
Acceptance and Filing Reviews for Premarket Approval Applications; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Acceptance and Filing Reviews 
for Premarket Approval Applications (PMAs).'' The purpose of the 
acceptance and filing reviews is to make a threshold determination 
about whether an application is administratively complete. This 
guidance document is intended to clarify the criteria for accepting and 
filing a PMA, thereby assuring the consistency of our acceptance and 
filing decisions. This guidance is applicable to original PMAs and PMA 
panel-track supplements reviewed in the Center for Devices and 
Radiological Health (CDRH) and the Center for Biologics Evaluation and 
Research (CBER).

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Acceptance and Filing Reviews for Premarket 
Approval Applications (PMAs)'' to the Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002; or Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, 
Silver Spring, MD 20993-0002, 301-796-6570; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

I. Background

    The PMA regulation (21 CFR 814.42(e)) identifies the criteria that, 
if not met, may serve as a basis for refusing to file a PMA. These 
criteria are discussed in the guidance document ``Guidance for Industry 
and FDA Staff Premarket Approval Application Filing Review,'' dated May 
1, 2003. This document has been used by FDA staff and the device 
industry to help elucidate the broad preclinical and clinical issues 
that need to be addressed in a PMA and the key decisions to be made 
during the filing process. The guidance entitled ``Acceptance and 
Filing Reviews for Premarket Approval Applications (PMAs)'' supersedes 
the guidance entitled ``Guidance for Industry and FDA Staff Premarket 
Approval Application Filing Review.''
    To further focus the Agency's review resources on complete 
applications, which will provide a more efficient approach to ensuring 
that devices that have a reasonable assurance of safety

[[Page 102]]

and effectiveness reach patients as quickly as possible, we have 
modified the PMA filing guidance. In this guidance entitled, 
``Acceptance and Filing Reviews for Premarket Approval Applications 
(PMAs),'' we have separated the requirements for PMA filing into: (1) 
Acceptance criteria and (2) filing criteria. Acceptance review involves 
an early assessment of the completeness of the application, and 
informing the applicant in a written response within the first 15 
calendar days of receipt of the application whether any administrative 
elements are missing, and if so, identifying the missing administrative 
element(s).
    In order to enhance the consistency of our acceptance and filing 
decisions and to help applicants understand the types of information 
FDA needs to conduct a substantive review of a PMA, this guidance and 
associated checklist clarify the necessary elements and contents of a 
complete PMA application. The process we outline is applicable to all 
devices reviewed in a PMA application. Acceptance and filing decisions 
will be made for all original PMA applications and panel-track PMA 
supplements.
    This guidance is not significantly different from the 2003 PMA 
guidance document. The ``preliminary questions'' remain the same and 
the ``filing review questions'' have been separated into ``acceptance 
decision questions'' (i.e., is the file administratively complete) and 
``filing decision questions'' (i.e., are data consistent with protocol, 
final device design, and proposed indications). In addition, it should 
be noted that this document is focused on the regulatory and scientific 
criteria for making an ``Accept'' or ``Refuse to Accept'' decision as 
well as ``File'' or ``Not File'' decision for a PMA. It specifically 
does not alter the following administrative aspects of the PMA filing 
process: (1) The time frame for the filing review phase (i.e., 45 
days); (2) the processes for document tracking, distribution, and 
handling; and (3) the procedures for assembling the review team and 
setting up the filing meeting.
    In the Federal Register of July 31, 2012 (77 FR 45357), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by September 14, 2012. Nine comments 
were received with multiple recommendations pertaining to the 
administrative processes and policies regarding acceptance and filing 
review decisions. In response to these comments, FDA revised the 
guidance document to clarify the processes and policies as appropriate. 
This guidance supersedes the guidance entitled ``Guidance for Industry 
and FDA Staff Premarket Approval Application Filing Review,'' dated May 
1, 2003.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on acceptance and filing reviews for PMAs. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from the 
CBER internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive 
``Acceptance and Filing Reviews for Premarket Approval Applications 
(PMAs),'' you may either send an email request to dsmica@fda.hhs.gov to 
receive an electronic copy of the document or send a fax request to 
301-847-8149 to receive a hard copy. Please use the document number 
1792 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814, subpart B, have been 
approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: December 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31476 Filed 12-31-12; 8:45 am]
BILLING CODE 4160-01-P