Compliance Regulations and Guidance Affecting your Industry

This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States. This law amended sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (the Act), as well as section 351(h) of the Public Health Service Act, simplifying the requirements for exporting unapproved human drugs, biological products, and devices. In addition, the FDA Export Reform and Enhancement Act substantially reduced the requirements for exporting unapproved new animal drugs and provided a new option for exporting unapproved devices.

The 1996 Amendments did not change the general export requirements in section 801(e)(1) of the Act with respect to foods or cosmetics. This document provides guidance on these general export requirements under section 801(e)(1) of the Act for all products that are subject to this provision. Guidance is also provided on the export requirements for unapproved human drugs, biological products and devices in sections 801 and 802 of the Act resulting from the 1996 Amendments.

This guideline informs interested persons on certain practices and procedures for the preparation of investigational new drug products for human and animal use that may be useful to persons seeking to comply with certain sections of the current good manufacturing practices (CGMP) regulations for finished pharmaceuticals (Title 21 of the Code of Federal Regulation, Parts 210 and 211)

 

This guidance explains how your business may qualify as a “small business” and pay most FY 2011 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).

This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.

This guidance addresses new and abbreviated new (human and veterinary) drug application products and specified biologics regulated by CDER and CVM as well as nonapplication drug products. Within this scope, the guidance is applicable to all manufacturers of drug substances, drug products, and specified biologics (including intermediate and drug product components) over the life cycle of the products (references to 21 CFR part 211 are merely examples of related regulation). Within the context of this guidance, the term manufacturers includes human drug, veterinary drug, and specified biologic sponsors and applicants (21 CFR 99.3(f)).

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

Effective Date: This rule is effective March 7, 2011.
 

The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA established January 2, 2012, as the uniform compliance date for food labeling regulations issued between January 1, 2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; therefore the uniform compliance date was January 2, 2012).

DATES: This rule is effective December 15, 2010. Submit either electronic or written comments by February 14, 2011. 

This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.

This guidance applies to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

Section 904(e) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) (21 U.S.C. 387d(e)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) requires FDA to establish a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand (the HPHC list). This guidance document discusses the meaning of “harmful and potentially harmful constituent” in the context of implementing the HPHC list requirement.

This guidance provides information in response to questions related to the use of “light,” “mild,” “low,” or similar descriptors in the label, labeling, or advertising of tobacco products, as provided in section 911(b) of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (Public Law 111-31).

This guidance document is intended to provide information related to FDA's enforcement policy concerning Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by Section 204 of the Family Smoking Prevention and Tobacco Control Act. Section 204 of the Tobacco Control Act amended Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the “Smokeless Tobacco Act,” 15 U.S.C. 4402), to prescribe new requirements for health warning labels that must appear on smokeless tobacco product packages and advertising, and to require that rotational warning plans for packaging and advertising for smokeless tobacco products be submitted to FDA, rather than to the Federal Trade Commission (FTC).

This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics. This guidance applies to clinical investigations conducted under 21 CFR Part 312 (Investigational New Drug Applications or IND regulations). It describes how to complete the Statement of Investigator form (Form FDA 1572).

This draft guidance is intended to assist manufacturers, distributors, retailers, and others who sell cigarettes and/or smokeless tobacco in understanding the final Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents and to explain what you should do in order to comply with the regulations.

The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. This interim final rule represents the first step in an incremental approach to adopting standards, implementation specifications, and certification criteria to enhance the interoperability, functionality, utility, and security of health information technology and to support its meaningful use. The certification criteria adopted in this initial set establish the capabilities and related standards that certified electronic health record (EHR) technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs.
 

Effective Date: This interim final rule is effective February 12, 2010. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of February 12, 2010.

 

This draft guidance document was developed as a special controls guidance for powered muscle stimulators that are indicated for rehabilitation. If proposed 21 CFR 890.5850(a) is finalized, a powered muscle stimulator for rehabilitation will be defined as an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for use of an ivermectin injectable solution in cattle and swine for treatment and control of various internal and external parasites.

DATES: This rule is effective May 12, 2010.

 

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for the veterinary prescription use of an oral suspension containing orbifloxacin for the treatment of various bacterial infections in dogs and cats.

DATES: This rule is effective May 12, 2010.

 

This is the third edition of the Compliance Guideline for Controlling Salmonella and Campylobacter in Poultry. This update includes additional pre-harvest recommendations for controlling Salmonella and Campylobacter. Future editions will continue to reflect feedback received from all stakeholders. This Compliance Guideline follows the procedures for guidance documents in the Office of Management and Budget’s (OMB) “Final Bulletin for Agency Good Guidance Practices” (GGP).

This Compliance Guideline represents current FSIS thinking on this topic and should be considered usable as of this issuance. This guideline for poultry articulates how industry can meet FSIS expectations regarding control of food safety hazards. The guidelines summarize known control points for Salmonella and Campylobacter in the pre- and post-harvest production process, and include summaries of scientific studies that can be used to support specific control parameters. The guidelines will be updated as needed to reflect the most current information available to FSIS and stakeholders.

This is the second edition of the Compliance Guideline for poultry slaughter. This update includes recommendations for controlling both Salmonella and Campylobacter. Future editions will continue to reflect feedback received from all stakeholders. In order to make this guideline as useful as possible, FSIS encourages all persons interested to submit their comments and concerns regarding any aspect of this document including but not limited to: content, readability, applicability, and accessibility.

This is the first edition of the Compliance Guideline regarding Salmonella control in poultry slaughter. This compliance guideline describes concerns and validated controls for each step in the broiler slaughter process. In order to make this guideline as useful as possible, FSIS encourages all persons interested to submit their comments and concerns regarding any aspect of this document including but not limited to: content, readability, applicability, and accessibility.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Medical Device User Fee Cover Sheet— Form FDA 3601’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.