USFDA : Guidance for Industry - Critical Path Innovation Meetings...

Today, the U.S. Food and Drug Administration released a draft guidance: “Procedures for Meetings of the Medical Devices Advisory Committee.”  

Advisory committees play an important role in the FDA’s regulation of medical devices by providing independent expert advice on complex scientific and technical matters.

This new draft guidance describes the general circumstances in which FDA’s Center for Devices and Radiological Health (CDRH) convenes a panel of the Medical Devices Advisory Committee. The guidance also discusses the process and timelines for the exchange of information between CDRH and the members of the panel, industry, and the public. 

CDRH Industry: Guidance for Industry and Food and Drug Administration Staff - Design Considerations for Devices Intended for Home Use

This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. 

Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. 

This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.

To download the Document CLICK HERE

USFDA CDRH Webinar on Distinguishing Medical Device Recalls from Medical Device Enhancements conducted on 5th Nov 2014..

Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance

Summary: The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement.

The guidance contains clear definitions and practical examples to help manufacturers distinguish a recall from an enhancement. Correctly identifying a change to a device as a recall reduces the time between identification of a device defect/failure and public notification.

Clarifying when a change to a device represents a recall or an enhancement will help manufacturers better understand when reporting device changes to the FDA is required.

View/Download Printable Slides of the Webinar CLICK HERE

USFDA : Social Media Promotion !!! OPDP Reopens Comment Period for Two Draft Social Media Guidances...

In response to a request for additional time and to allow interested persons more time to submit comments, FDA is reopening the comment period for the two draft social media guidances that published on June 17, 2014.

Beginning September 29, 2014, the public will have an additional 30 days to provide comments on the draft guidances—“Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

To view USFDA's Social Media Guidances Webpage CLICK HERE

USFDA : Draft Guidance for Industry : Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices

A draft guidance has been posted titled, "Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices."  FDA is issuing this guidance to provide industry and agency staff with recommendations for 100 the suggested format and content of an Abbreviated 510(k) submission for early growth 101 response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen 102 characterization devices and recommendations for addressing certain labeling issues relevant 103 to the review process specific to these devices.  

To view/download the draft guidance, please CLICK HERE

USFDA CDER Guidance Document : Custom Device Exemption...

A guidance document has been posted regarding the Custom Device Exemption. 

The Food and Drug Administration (FDA) has developed this document to provide guidance to industry and FDA staff about implementation of the custom device exemption contained in Section 520(b) the Food, Drug and Cosmetic Act (FD&C Act). 

The guidance provides definitions of terms used in the custom device exemption, explains how FDA interprets the “5 units per year of a particular device type” language contained in section 520(b)(2)(B) of the FD&C Act, describes what information should be submitted in a Custom Device Annual Report (“annual report”), and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption.  

To view/download the guidance, please CLICK HERE

USFDA Final Guidance for Industry: ANDA Submissions - Refuse-to-Receive Standards and ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits

FDA published notices in the Federal Register announcing the availability of one final and one draft guidance for industry:

• Guidance For Industry: ANDA Submissions - Refuse-to-Receive Standards (RTR Standards guidance) (Final Guidance):  Assists applicants preparing to submit abbreviated new drug applications (ANDAs), and related submissions (i.e., prior approval supplements (PASs) for new strengths).  The guidance highlights serious deficiencies in the application ANDA or new strength PAS that may cause FDA to refuse-to-receive the submission. 

• Draft Guidance for Industry: ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (RTR Impurities guidance):  Assists applicants preparing to submit to FDA ANDAs and PASs to ANDAs, for which the applicant is seeking approval of a new strength of the drug product.  Highlights deficiencies in information about impurities that may cause FDA to refuse-to-receive an ANDA or new strength PAS. 

These guidances provide applicants with information on deficiencies that may cause FDA to refuse to receive an ANDA or new strength PAS.  FDA is issuing these guidances as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.

A pre-recorded webinar explaining these guidances is available at:

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - “Guidance for Industry: ANDA Submissions-Refuse-to-Receive Standards” and “Draft Guidance for Industry: ANDA Submissions-Refuse-to-Receive for Lack of Proper Justification of Impurity Limits.” – September 16, 2014

 

USFDA CDRH Webinar on "Medical Devices in the Home: Design Considerations and Guidance for Industry"

USFDA CDRH has uploaded recorded webinar, printable slides and transcript for the Webinar

"Medical Devices in the Home: Design Considerations and Guidance for Industry"

Please view/download

Recorded Webinar

Printable Slides (PDF)

Transcripts (PDF)

For other webinars posted by CDRH on Medical Devices - CLICK HERE

USFDA Guidance for Industry: Electronic Submission of Lot Distribution Records

USFDA has recently issued a draft guidance for industry comments on Electronic Submission of Lot Distribution Records.

This guidance provides you, licensed manufacturers of products distributed under an approved biologics license application (BLA) (henceforth referred to as applicants), with recommendations on how to submit lot distribution reports (LDRs) for biological products in an electronic format that FDA can process, review, and archive. 

For Detailed Copy of the Draft Guidance on Electronic Submission of Lot Distribution Records CLICK HERE

Guidance for Industry: CDRH - Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices

A guidance document titled, "Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices" has recently been posted.  

This document recommends studies for establishing the performance characteristics of HMMDs. 

FDA considers these recommended studies to be relevant for premarket notifications (e.g., 510(k) or de novo) that may be required for a particular device.  

To view the guidance, please CLICK HERE

USFDA Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development

Today FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry:

·           Controlled Correspondence Related to Generic Drug Development

This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development.  This guidance also describes FDA’s process for providing communications related to such correspondence.  FDA is issuing this draft guidance as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.

A pre-recorded webinar explaining this draft guidance is available at:

CDER Small Business and Industry Assistance (CDER SBIA) Webinar “Draft Guidance for Industry on Controlled Correspondence Related to Generic Drug Development”

– August 26, 2014

Submit electronic comments on the draft guidances to the Federal Register docket.

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.