81 FR 3436 - Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3436-3438 | |
| FR Document | 2016-01093 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Notices] [Pages 3436-3438] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01093] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0611] Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.'' This guidance updates and clarifies the information regarding sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. The recommendations in this guidance will be implemented on March 21, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: [[Page 3437]]Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2008-D-0611 for ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Alternatively, you may submit written requests for single copies of the guidance document to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background In recent years, FDA has received an increasing number of 510(k)s for devices labeled as sterile that are sterilized during the manufacturing process by methods other than the traditionally used methods (i.e., steam, dry heat, ethylene oxide (EO), and radiation). FDA has experience with some of the other methods and now considers them to be established methods. However, there may be alterations to the more recently developed methods. In addition, original, innovative sterilization technologies are being developed and proposed. FDA considers these to be novel methods, which carry a substantial risk of inadequate sterility assurance. Consequently, devices sterilized using these technologies may not comply with Good Manufacturing Practice. Failure to assure sterility presents a serious risk to human health because of the risk of infection. Therefore, we intend to inspect the manufacturing facility before clearing a 510(k) for a device that is sterilized by a novel sterilization process. We believe inspecting the manufacturing facility for devices sterilized using these novel sterilization technologies will help ensure the safety and effectiveness of these devices and mitigate the risks to human health. This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that we recommend sponsors include in a 510(k) submission. In the Federal Register of December 12, 2008 (73 FR 75724), FDA announced the availability of the draft of this guidance. Interested persons were invited to comment by March 12, 2009. FDA considered the public comments received and revised the guidance, where applicable. This [[Page 3438]] document supersedes ``Updated 510(k) Sterility Review Guidance K90-1'' dated August 30, 2002. 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 current thinking of FDA on submission and review of sterility information in 510(k)s for devices labeled as sterile. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of ``Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1615 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously 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 approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073. Dated: January 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-01093 Filed 1-20-16; 8:45 am] BILLING CODE 4164-01-P
![3436 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
Ave., Bldg. 51, Rm. 6286, Silver Spring, LDL–C to target levels; and (3) as an safety or effectiveness. FDA will not
MD 20993–0002, 240–402–1748. adjunct to diet for the reduction of begin procedures to withdraw approval
SUPPLEMENTARY INFORMATION: In 1984, elevated total-C and LDL–C levels in of approved ANDAs that refer to
Congress enacted the Drug Price patients with primary MEVACOR (lovastatin) tablets, 20 mg
Competition and Patent Term hypercholesterolemia (Types IIa and and 40 mg. Additional ANDAs that refer
Restoration Act of 1984 (Pub. L. 98–417) IIb), when the response to diet restricted to these products may also be approved
(the 1984 amendments), which in saturated fat and cholesterol and to by the Agency as long as they meet all
authorized the approval of duplicate other nonpharmacological measures other legal and regulatory requirements
versions of drug products under an alone has been inadequate. MEVACOR for the approval of ANDAs. If FDA
ANDA procedure. ANDA applicants is also indicated as an adjunct to diet to determines that labeling for these drug
must, with certain exceptions, show that reduce total-C, LDL–C, and products should be revised to meet
the drug for which they are seeking apolipoprotein B levels in adolescent current standards, the Agency will
approval contains the same active boys and girls who are at least 1 year advise ANDA applicants to submit such
ingredient in the same strength and post-menarche, 10–17 years of age, with labeling.
dosage form as the ‘‘listed drug,’’ which heterozygous familial Dated: January 14, 2016.
is a version of the drug that was hypercholesterolemia if, after an
Leslie Kux,
previously approved. ANDA applicants adequate trial of diet therapy, the
following findings are present: (1) LDL– Associate Commissioner for Policy.
do not have to repeat the extensive [FR Doc. 2016–01096 Filed 1–20–16; 8:45 am]
clinical testing otherwise necessary to C remains >189 mg/deciliter (dL) or (2)
gain approval of a new drug application LDL–C remains >160 mg/dL and there is BILLING CODE 4164–01–P
(NDA). a positive family history of premature
The 1984 amendments include what cardiovascular disease (CVD) or two or
more other CVD risk factors are present DEPARTMENT OF HEALTH AND
is now section 505(j)(7) of the Federal HUMAN SERVICES
Food, Drug, and Cosmetic Act (21 U.S.C. in the adolescent patient.
MEVACOR (lovastatin) tablets, 20 mg
355(j)(7)), which requires FDA to Food and Drug Administration
and 40 mg, are currently listed in the
publish a list of all approved drugs.
‘‘Discontinued Drug Product List’’ [Docket No. FDA–2008–D–0611]
FDA publishes this list as part of the
section of the Orange Book.
‘‘Approved Drug Products With Winifred M. Begley submitted a Submission and Review of Sterility
Therapeutic Equivalence Evaluations,’’ citizen petition dated September 10, Information in Premarket Notification
which is known generally as the 2015 (Docket No. FDA–2015–P–3319), (510(k)) Submissions for Devices
‘‘Orange Book.’’ Under FDA regulations, under 21 CFR 10.30, requesting that the Labeled as Sterile; Guidance for
drugs are removed from the list if the Agency determine whether MEVACOR Industry and Food and Drug
Agency withdraws or suspends (lovastatin) tablets, 20 mg and 40 mg, Administration Staff; Availability
approval of the drug’s NDA or ANDA were withdrawn from sale for reasons of
for reasons of safety or effectiveness or safety or effectiveness. AGENCY: Food and Drug Administration,
if FDA determines that the listed drug After considering the citizen petition HHS.
was withdrawn from sale for reasons of and reviewing Agency records and ACTION: Notice of availability.
safety or effectiveness (21 CFR 314.162). based on the information we have at this
A person may petition the Agency to SUMMARY: The Food and Drug
time, FDA has determined under
determine, or the Agency may Administration (FDA or Agency) is
§ 314.161 that MEVACOR (lovastatin)
determine on its own initiative, whether announcing the availability of the
tablets, 20 mg and 40 mg, were not
a listed drug was withdrawn from sale guidance entitled ‘‘Submission and
withdrawn for reasons of safety or
for reasons of safety or effectiveness. Review of Sterility Information in
effectiveness. The petitioner has
This determination may be made at any Premarket Notification (510(k))
identified no data or other information
time after the drug has been withdrawn suggesting that MEVACOR (lovastatin) Submissions for Devices Labeled as
from sale, but must be made prior to tablets, 20 mg and 40 mg, were Sterile.’’ This guidance updates and
approving an ANDA that refers to the withdrawn for reasons of safety or clarifies the information regarding
listed drug (§ 314.161 (21 CFR 314.161)). effectiveness. We have carefully sterilization processes that FDA
FDA may not approve an ANDA that reviewed our files for records recommends sponsors include in
does not refer to a listed drug. concerning the withdrawal of 510(k)s for devices labeled as sterile.
MEVACOR (lovastatin) tablets, 20 mg MEVACOR (lovastatin) tablets, 20 mg This guidance document also provides
and 40 mg, are the subject of NDA 19– and 40 mg, from sale. We have also details about the pyrogenicity
643, held by Merck & Co. Inc., and independently evaluated relevant information that FDA recommends
initially approved on August 31, 1987. literature and data for possible sponsors include in a 510(k)
MEVACOR is indicated: (1) To reduce postmarketing adverse events. We have submission.
the risk of myocardial infarction, found no information that would DATES: Submit either electronic or
unstable angina, and coronary indicate that this product was written comments on this guidance at
revascularization procedures in withdrawn from sale for reasons of any time. General comments on Agency
individuals without symptomatic safety or effectiveness. guidance documents are welcome at any
cardiovascular disease, average to Accordingly, the Agency will time. The recommendations in this
asabaliauskas on DSK9F6TC42PROD with NOTICES
moderately elevated total cholesterol continue to list MEVACOR (lovastatin) guidance will be implemented on March
(total-C) and low-density lipoprotein tablets, 20 mg and 40 mg, in the 21, 2016.
cholesterol (LDL–C), and below average ‘‘Discontinued Drug Product List’’ ADDRESSES: You may submit comments
high-density lipoprotein cholesterol; (2) section of the Orange Book. The as follows:
to slow the progression of coronary ‘‘Discontinued Drug Product List’’
atherosclerosis in patients with delineates, among other items, drug Electronic Submissions
coronary heart disease as part of a products that have been discontinued Submit electronic comments in the
treatment strategy to lower total-C and from marketing for reasons other than following way:
VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1](https://thefederalregister.org/doc/81_FR_3449/page/1.svg)
![3438 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
document supersedes ‘‘Updated 510(k) DEPARTMENT OF HEALTH AND adverse event reporting and
Sterility Review Guidance K90–1’’ dated HUMAN SERVICES recordkeeping for dietary supplements
August 30, 2002. and non-prescription drugs marketed
Food and Drug Administration without an approved application.
II. Significance of Guidance Section 761(b)(1) of the FD&C Act (21
[Docket No. FDA–2007–D–0372]
This guidance is being issued U.S.C. 379aa–1(b)(1)) requires the
Agency Information Collection manufacturer, packer, or distributor
consistent with FDA’s good guidance
Activities; Submission for Office of whose name under section 403(e)(1) of
practices regulation (21 CFR 10.115).
Management and Budget Review; the FD&C Act (21 U.S.C. 343(e)(1)))
The guidance represents the current
Comment Request; Adverse Event appears on the label of a dietary
thinking of FDA on submission and supplement marketed in the United
review of sterility information in 510(k)s Reporting and Recordkeeping for
Dietary Supplements as Required by States to submit to us all serious adverse
for devices labeled as sterile. It does not event reports associated with the use of
establish any rights for any person and the Dietary Supplement and
Nonprescription Drug Consumer a dietary supplement, accompanied by a
is not binding on FDA or the public. copy of the product label. The
Protection Act
You can use an alternative approach if manufacturer, packer, or distributor of a
it satisfies the requirements of the AGENCY: Food and Drug Administration, dietary supplement is required by the
applicable statutes and regulations. HHS. DSNDCPA to use the MedWatch Form
ACTION: Notice. FDA 3500A when submitting a serious
III. Electronic Access
adverse event report to FDA. In
SUMMARY: The Food and Drug addition, under section 761(c)(2) of the
Persons interested in obtaining a copy
Administration (FDA) is announcing FD&C Act, the submitter of the serious
of the guidance may do so by that a proposed collection of
downloading an electronic copy from adverse event report (referred to in the
information has been submitted to the statute as the ‘‘responsible person’’) is
the Internet. A search capability for all Office of Management and Budget
Center for Devices and Radiological required to submit to FDA a follow-up
(OMB) for review and clearance under report of any related new medical
Health guidance documents is available the Paperwork Reduction Act of 1995.
at http://www.fda.gov/MedicalDevices/ information the responsible person
DATES: Fax written comments on the receives within 1 year of the initial
DeviceRegulationandGuidance/ collection of information by February report.
GuidanceDocuments/default.htm. 22, 2016. Section 761(e)(1) of the FD&C Act (21
Guidance documents are also available U.S.C. 379aa–1(e)(1)) requires that
ADDRESSES: To ensure that comments on
at http://www.fda.gov/BiologicsBlood the information collection are received, responsible persons maintain records
Vaccines/GuidanceCompliance OMB recommends that written related to the dietary supplement
RegulatoryInformation/Guidances/ comments be faxed to the Office of adverse event reports they receive,
default.htm or http:// Information and Regulatory Affairs, whether or not the adverse event is
www.regulations.gov. Persons unable to OMB, Attn: FDA Desk Officer, FAX: serious. Under the statute, the records
download an electronic copy of 202–395–7285, or emailed to oira_ must be retained for a period of 6 years.
‘‘Submission and Review of Sterility submission@omb.eop.gov. All As required by section 3(d)(3) of the
Information in Premarket Notification comments should be identified with the DSNDCPA, we issued guidance to
(510(k)) Submissions for Devices OMB control number 0910–0635. Also describe the minimum data elements for
Labeled as Sterile’’ may send an email include the FDA docket number found serious adverse event reports for dietary
request to CDRH-Guidance@fda.hhs.gov in brackets in the heading of this supplements. In the Federal Register of
to receive an electronic copy of the document. July 14, 2009 (74 FR 34024), we
document. Please use the document announced the availability of guidance
FOR FURTHER INFORMATION CONTACT: FDA
number 1615 to identify the guidance entitled ‘‘Guidance for Industry:
PRA Staff, Office of Operations, Food Questions and Answers Regarding
you are requesting. and Drug Administration, 8455 Adverse Event Reporting and
IV. Paperwork Reduction Act of 1995 Colesville Rd., COLE–14526, Silver Recordkeeping for Dietary Supplements
Spring, MD 20993–0002, PRAStaff@ as Required by the Dietary Supplement
This guidance refers to previously fda.hhs.gov. and Nonprescription Drug Consumer
approved collections of information SUPPLEMENTARY INFORMATION: In Protection Act’’. The guidance discusses
found in FDA regulations. These compliance with 44 U.S.C. 3507, FDA how, when, and where to submit serious
collections of information are subject to has submitted the following proposed adverse event reports for dietary
review by the Office of Management and collection of information to OMB for supplements and follow-up reports. The
Budget (OMB) under the Paperwork review and clearance. guidance also provides our
Reduction Act of 1995 (44 U.S.C. 3501– recommendation on records
3520). The collections of information in Adverse Event Reporting and maintenance and access for serious and
21 CFR part 807, subpart E, have been Recordkeeping for Dietary Supplements non-serious adverse event reports, and
approved under OMB control number as Required by the Dietary Supplement related documents.
0910–0120; and the collections of and Nonprescription Drug Consumer The guidance recommends that the
information in 21 CFR part 820 have Protection Act—21 U.S.C. 379aa–1(b)(1) responsible person document their
asabaliauskas on DSK9F6TC42PROD with NOTICES
been approved under OMB control OMB Control Number 0910–0635— attempts to obtain the minimum data
number 0910–0073. Extension elements for a serious adverse event
Dated: January 14, 2016. The Dietary Supplement and report. Along with these records, the
Nonprescription Drug Consumer guidance recommends that the
Leslie Kux,
Protection Act (the DSNDCPA) (Pub. L. responsible person keep the following
Associate Commissioner for Policy. 109–462, 120 Stat. 3469) amends the other records: (1) Communications
[FR Doc. 2016–01093 Filed 1–20–16; 8:45 am] Federal Food, Drug, and Cosmetic Act between the responsible person and the
BILLING CODE 4164–01–P (the FD&C Act) with respect to serious initial reporter of the adverse event and
VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1](https://thefederalregister.org/doc/81_FR_3449/page/3.svg)
Document Created: 2018-02-02 12:34:01
Document Modified: 2018-02-02 12:34:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. The recommendations in this guidance will be implemented on March 21, 2016. | |
| Contact | Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 3436 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR