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News and Info

15 May

Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs (FSVP) Regulation.

The FDA new guidance provides information on how the importers will comply with FDA’s requirement to identify themselves as the importer of a food at entry into the United States under the Foreign Supplier Verification Programs (FSVP) regulation, including the requirement to provide a unique facility identifier (UFI) recognized as acceptable by FDA. On March

Apr

FDA wants you to address the concern about Cyber-security – Risk Management Issue for your Medical Device!!

The need for effective cyber-security to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information. FDA recognizes that medical device security is a shared responsibility between stakeholders, including health care facilities, patients, providers,

10 Apr

Good News!! FDA Extends deadline for eCTD DMF Submission to May 5, 2018!!

As per the requirements under the FD&C Act, FDA issued guidance on May 5, 2015 “Guidance on Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” which established a mandatory requirement for eCTD submission for NDA, BLA, IND, ANDA, and DMF. Submissions that are not

  • DUNS number
03 Apr

DUNS number is now Unique Facility Identifier for Importers!! FDA Recognizes DUNS Number as Acceptable for Importer Identification!!

The U.S. Food and Drug Administration today took a step towards ensuring the accuracy of its inventory of importers responsible for meeting the requirements of the Foreign Supplier Verification Programs (FSVP) rule. The FDA issued guidance formally recognizing the Data Universal Numbering System (DUNS) number as an acceptable unique facility identifier (UFI) for FSVP. The

27 Mar

FDA Announces the 2017 CDRH Experiential Learning Program (ELP)!!

CDRH offers an innovative learning opportunity for new and experienced review staff. The Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices.  Because technology continuously evolves, it is essential that CDRH review staff members are aware of

21 Mar

MDSAP AND A MDSAP AUDIT EXPERIENCE

by ALAN SCHWARTZ ABSTRACT The Medical Device Single Audit Program (MDSAP) is a new medical device auditing plan with potential for several advantages. This discussion addresses an actual MDSAP audit experience and demonstrates how the organization dealt with its complexities. The MDSAP program is described including country involvements. Audit personnel and experiences are discussed. Example

15 Mar

Give your Comments and get Exemptions from Premarket Notification for some Class II Devices!!

FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA’s initial determination

Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
17 Feb

Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions

Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions. This guidance document explains the principal factors that FDA considers when assessing benefits and risks of original IDE applications, IDE amendments and IDE supplements for human clinical investigations of certain medical devices to determine safety and effectiveness. The approach

18 Jan

FDA provides updated information on 3D Printing of Medical Devices.

FDA provides updated information on 3D Printing of Medical Devices. 3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD)

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