Field Alert Reports – FDA Introduces the Automated Form 3331a The Federal Food, Drug and Cosmetic Act, section 505(k) requires New Drug Application (NDA) holders to provide a Field Alert Report, on distributed drug product, to the Agency with any information concerning any incident that causes the drug product or its labeling to be mistaken
FDA Intends to Extend Compliance Dates for Agricultural Water Standards!! The FDA Food Safety Modernization Act (FSMA) Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. Agricultural water can be a major conduit of pathogens that can
FDA intends to extend the compliance dates for the unique device identification system (UDI system) requirements for Class I and unclassified device! On September 24, 2013, FDA published a final rule establishing a unique device identification system, including unique device identifier (UDI) labeling and data submission requirements (78 FR 58786) (the UDI Rule). Generally, under
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
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,
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
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
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
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
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
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