UPDATING REGULATIONS IN RECOGNITION OF CHANGING TECHNOLOGY

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Agency

Purpose

Impact

21 CFR 310

21 CFR 414

21 CFR 600

Postmarketing Safety Reports for Human Drugs and Biological Products; Electronic Submission Requirements (e-SADR)

FDA/CDER

FDA is revising its regulations to allow mandatory safety reports to be transmitted electronically.

Would allow FDA to collect and analyze safety reports more quickly and to identify emerging problems faster and disseminate info.

21 CFR 314

21 CFR 601

Electronic Submission of Clinical Study Data (e-CSD)

FDA/CDER

FDA is revising its regulations to require submission of data in drug applications in electronic format that FDA can process, review and archive.

Use of modern technology would increase efficiency and allow for more comprehensive data review.

21 CFR 201

Electronic Distribution of Prescribing Information for Human Prescription Drugs and Biological Products (e-Labeling)

FDA/OP

This rule would require electronic “package inserts “for human drug and biological products.

Up-to-date prescribing information for healthcare professionals.

21 CFR 207

Electronic Registration and Listing for Drugs (e-DRLS)

FDA-CDER

Would convert the registration and listing process to a paperless system, while maintaining an avenue for companies that do not have access to the web.

Would allow for the utilization of latest technology in the collection of information and improve FDA’s ability to inspect manufacturing establishments.

21 CFR 807

Electronic Registration and Listing for medical devices

FDA/CDRH

Would convert the registration and listing process to a paperless system, while maintain an avenue for companies that do not have access to the web.

Would allow for the utilization of latest technology in the collection of information.

21 CFR 4

Current Good Manufacturing Practices (CGMPs) for Combination Products

FDA/OC

Would clarify and codify CGMPs requirements for products that are combinations of drug, device and/or biological products.

Would provide regulatory clarity for manufacturers of combination products.

21 CFR 4

Postmarketing Safety Reporting for Combination Products

FDA/OC

Would clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product was approved.

Would provide regulatory clarity for manufacturers of combination products.

FDA MEDICAL PRODUCTS

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Reference

Agency

Purpose

Impact

21 CFR 803

Electronic Medical Device Reporting

FDA/CDRH

Would convert adverse events reporting of medical devices to a paperless system.

Would allow paperless reporting of adverse events

21 CFR

Down-classifications of Medical Devices (various)

FDA/CDRH

Review classifications of medical devices to determine if down-classification (i.e., move to a classification with less stringent requirements) is appropriate.

Regulate based on risks and reduce regulatory burden.

21 CFR 814

Revision of Device Premarket Approval Regulations (21 CFR 814.39); Special PMA Supplement Changes Being Effected

FDA/CDRH

Remove duplicative requirements

Streamline and clarify regulatory requirements.

21 CFR 882

Revise 21 CFR 882.5975 referencing device classification for dura mater, now regulated as an HCT/P

FDA/CDRH

Clarify classification of dura mater.

Clarification of regulatory status

21 CFR 351

21 CFR 360

21 CFR 371

General Hospital and Personal Use Devices; Issuance of Draft Special Controls for Infusion Pumps

FDA/CDRH

Based on an analysis of death and serious injury reports submitted to FDA, the agency is establishing special controls to provide reasonable assurance of safety and effectiveness of these devices.

Increased safety for patients.

21 CFR 801

Use of Symbols in Device Labeling

FDA/CDRH

Allow validated symbols in certain device labeling without the need for accompanying English text.

 Reduce burden of labeling requirements by permitted harmonization with labeling for international markets

21 CFR 10

21 CFR 314

21 CRF 600

21 CFR 601

21 CFR 606

Postmarketing Safety Reporting Requirements for Human Drugs and Biological Products

FDA/CDER

FDA is revising certain definitions and reporting requirements based on recommendation of the ICH.

Revise reporting requirements and times to enhance the quality of safety reports received by FDA.

21 CFR 201

21 CFR 606

Bar Code Rule for Drugs

FDA/CDER & CBER

FDA is conducting a retrospective economic review of economically significant regulation.

Assess costs and benefits to determine if rule should be modified to take into account changes in technology that have occurred since the rule went into effect.

21 CFR210

21 CFR 211

Amendment to CGMP regulations for Finished Pharmaceuticals (Pharmaceutical CGMP for the 21st Century--Phase 2)

FDA/CDER

FDA is revising its CGMP regulations to accommodate advances in technology and to harmonize with the other International standards.

Flexibility and harmonization for pharmaceutical industry.

21 CFR 210

21 CFR 211

Amendment to CGMP regulations—Components

FDA/CDER

FDA is revising its CGMP regulations to address control of drug components.

Provide greater assurances of safety and quality and address some of the challenges of globalization of drug manufacturing.

21 CFR 314

Implementation of 505(q) – Amendment To Citizen Petitions, Petitions for Stay of Action and Submissions of Documents to Dockets

FDA/CDER

FDA is revising its existing regulations to implement provisions of the FDA Amendment Act.

Clarify certifications needed when filing petitions related to generic drug applications.

21 CFR 201

21 CFR 208

Patient Labeling for Drugs (Patient Package Inserts and Medguides)

FDA/CDER

 TBD

TBD

FDA FOODS

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Agency

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Impact

21 CFR 101

Food Labeling (Nutrition Initiative)

FDA/CFSAN

Revising and updating food labeling regulations to make nutrition information on packaged food label more useful to consumers.

Improving nutrition information will help consumers make better dietary choices.

21 CFR 110

Preventive Controls (Modernization of Current Food Good Manufacturing Practice Regulations)

FDA/CFSAN

In recognition that existing food GMP rules are inadequate, the Food Safety Modernization Act requires FDA to establish preventive controls for food facilities.

Reduced illness and death from food-borne illness.

OTHER REVIEWS CONSISTENT WITH E.O. 13563

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21 CFR 606

21 CFR 630

General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification

FDA/CBER

FDA is reviewing this regulation as required by sec. 610 (c) of the Regulatory Flexibility Act.

Fulfill requirements of Regulatory Flexibility Act.

21 CFR 203

21 CFR 205

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements and Administrative Procedures

FDA/CDER

FDA is reviewing this regulation as required by sec. 610 (c) of the Regulatory Flexibility Act.

Fulfill requirements of Regulatory Flexibility Act.

21 CFR 1002

21 CFR 1010

21 CFR 1040

Laser Products; Amendment to Performance Standards

FDA/CDRH

Amending the performance standards for laser products to achieve closer harmonization with the International Electrotechnical Commission (IEC) standards.

Would harmonize with the IEC and reflect current advances in science.

OTHER FDA RULES UNDER REVIEW

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Agency

Purpose

Impact

21 CFR 558

Veterinary Feed Directives

FDA/CVM

Improve efficiency of the process for veterinarians to issue feed directives.

Streamlined VFDs will assist veterinarians and medicated feed manufacturers.

21 CFR 514

21 CFR 510

New Animal Drugs—Records and Reports concerning experience with approved drugs and medicated feeds

FDA/CVM

Reviewing regulations to determine how to clarify, streamline, and harmonize.

Aligning with international standards and clarifying requirements will result in improved reporting by sponsors.

21 CFR 58

Good Laboratory Practice for Nonclinical Investigations

FDA/OC

Review standards for nonclinical investigations to determine how best to update them.

Update standards for nonclinical investigations.