Source: https://www.law.cornell.edu/cfr/text/21/1271.320
Timestamp: 2018-05-26 02:47:01
Document Index: 256823333

Matched Legal Cases: ['art 1271', '§ 1271', '§ 1271', '§ 1271', '§ 1271', 'art 1271']

21 CFR 1271.320 - Complaint file. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter L › Part 1271 › Subpart D › Section 1271.320
§ 1271.320 Complaint file.
(a)Procedures. You must establish and maintain procedures for the review, evaluation, and documentation of complaints as defined in § 1271.3(aa), relating to core current good tissue practice (CGTP) requirements, and the investigation of complaints as appropriate.
(b)Complaint file. You must maintain a record of complaints that you receive in a file designated for complaints. The complaint file must contain sufficient information about each complaint for proper review and evaluation of the complaint (including the distinct identification code of the HCT/P that is the subject of the complaint) and for determining whether the complaint is an isolated event or represents a trend. You must make the complaint file available for review and copying upon request from FDA.
(c)Review and evaluation of complaints. You must review and evaluate each complaint relating to core CGTP requirements to determine if the complaint is related to an HCT/P deviation or to an adverse reaction, and to determine if a report under § 1271.350 or another applicable regulation is required. As soon as practical, you must review, evaluate, and investigate each complaint that represents an event required to be reported to FDA, as described in § 1271.350. You must review and evaluate a complaint relating to core CGTP requirements that does not represent an event required to be reported to determine whether an investigation is necessary; an investigation may include referring a copy of the complaint to another establishment that performed manufacturing steps pertinent to the complaint. When no investigation is made, you must maintain a record that includes the reason no investigation was made, and the name of the individual(s) responsible for the decision not to investigate.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1271 after this date.
82 FR 54289 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability
FR Doc. 2017-24839
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.” The guidance document provides tissue establishments and health care professionals with FDA&apos;s current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.
82 FR 54290 - Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
FR Doc. 2017-24838
Docket No. FDA-2017-D-6146
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.” The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA&apos;s current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders&apos; understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.
81 FR 40512 - Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
FR Doc. 2016-14721
This rule is effective August 22, 2016.
The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
81 FR 23661 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments
FR Doc. 2016-09372
The public hearing will be held on September 12 and 13, 2016, from 9 a.m. to 5 p.m. The hearing on September 13 may be extended or end early depending on the number of speakers scheduled. Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. Persons (including FDA employees) seeking to attend in person or to attend and speak at the public hearing must register by June 1, 2016. FDA will notify registered speakers of their scheduled times, and make available an agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before July 1, 2016. Once FDA notifies registered speakers of their scheduled times, speakers should submit an electronic copy of their presentation to CBERPublicEvents@fda.hhs.gov by August 1, 2016. Section IV of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until September 27, 2016.
FR Doc. 2016-09366
Docket No. s. FDA-2014-D-1584, FDA-2014-D-1696, FDA-2014-D-1856, and FDA-2015-D-3581
Notification; extension of comment periods.
FDA is extending the comment period on the four draft guidances announced in the Federal Register (see SUPPLEMENTARY INFORMATION ). Submit either electronic or written comments by September 27, 2016.
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance documents entitled “Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry”; “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff”; “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry”; and ”Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The Agency is taking this action to allow interested persons additional time to submit comments and any new information.
80 FR 81233 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction
FR Doc. 2015-32686
The Food and Drug Administration (FDA or Agency) is correcting a notification of a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” that appeared in the Federal Register of October 30, 2015 (80 FR 66845). The document announced a public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The document published with conflicting information about who must register for the public hearing. This document corrects that error.
80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
FR Doc. 2015-27705
Docket No. FDA-2014-D-1696
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff,” published in the Federal Register of December 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
FR Doc. 2015-27703
The public hearing will be held on April 13, 2016, from 8 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Persons seeking to attend or to present at the public hearing must register by January 8, 2016. Section IV provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until April 29, 2016.
The Food and Drug Administration (FDA or Agency) is announcing a 1-day public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). These draft guidances were issued by FDA in response to stakeholders&apos; requests for guidance on FDA&apos;s current views about how manufacturers, establishments, and distributors of HCT/Ps and health care professionals can meet the criteria under the Agency&apos;s regulations that apply to HCT/Ps. FDA will consider information it obtains from the public hearing in the finalization of these guidances.
FR Doc. 2015-27707
The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry” announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
FR Doc. 2015-27706
FR Doc. 2015-27704
Docket No. FDA-2015-D-3581
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 29, 2016.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff, with recommendations for applying the criterion of “homologous use” as it applies to HCT/Ps. The interpretation and application of the homologous use criterion and related definitions have been of considerable interest to industry stakeholders since they were first proposed during the Agency&apos;s rulemaking on HCT/Ps.
79 FR 78744 - Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
FR Doc. 2014-30528
Submit either electronic or written comments on the proposed rule by March 31, 2015.
79 FR 77414 - Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Availability
FR Doc. 2014-30142
Notice of availability; request for comments on draft guidance.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 23, 2015.
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.
79 FR 63348 - Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability
FR Doc. 2014-25217
Request for comment on draft guidance.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 22, 2014
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception” dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements.