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23 Dec

FDA Update – FDA updates Q&A appendix in Guidance on Clinical Trials of Medical Products During COVID-19

The FDA has issued the guidance document, Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency, because the agency recognizes that the public health emergency caused by COVID-19 has impacted the conduct of clinical trials of medical products, including drugs, devices, and biologics. These challenges may arise from isolation practices, site closures,

BREXIT and Medical Device Registration
07 Dec

Industry Update: Interesting news on – BREXIT and Medical Device Registration

As of January 1, 2021, the UK’s departure from the EU will begin. As of that date, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the medical devices market for the UK that are currently undertaken through the EU system. This calls for several changes to how medical devices

30 Nov

FDA Update – FDA launces new program to support use of Novel Drug Development Tools

The FDA has just launched a new program, the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. This program is meant for developers of novel drug development tools (DDTs), allowing pathways for those developers to submit proposals for novel approaches that are currently without an existing regulatory path. The existing DDT qualification

Nov

FDA Update – Voluntary Qualified Importer Program Update

If you are unaware of the Voluntary Qualified Importer Program (VQIP), it is a voluntary fee-based program that allows for expedited review and import entry of food for humans and animals into the United States under the FDA Food and Safety Modernization Act (FSMA). The FDA has recently just approved 3 participants into this program;

25 Nov

Clearing a Path for Financing by Investors

Angels, venture capitalists and strategic partners don’t want to commit financial resources to help a manufacturer develop a new medical device if they feel they will not get adequate return on investment in a reasonable timeframe. That makes perfectly good sense. Such a manufacturer must first perform a preliminary analysis as to whether their medical

FDA Logo Policy
19 Oct

FDA Update: FDA Logo Policy

This is very important information for foreign companies where we have observed many companies trying to get an edge by saying such terms as “FDA approved”, or “FDA CERTIFIED”. Make sure you read this. The FDA logo is made up of two components, the Monogram and Wordmark. The combination of the two components is what

Oct

FDA Update: FDA establishes U.S. Agent Voluntary Identification System for Food Facilities

FDA Update – October 19, 2020 FDA establishes U.S. Agent Voluntary Identification System for Food Facilities The FDA is issuing a new guidance document, U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration. This is in conjunction with the FDA’s food facility registration database, the Food Facility Registration Module (FFRM). The purpose of the

12 Oct

Applying for a New CPT Code

Applying for a New CPT Code For almost all medical devices associated with a medical or surgical procedure, there must be a corresponding CPT code. It’s simple – if there is no CPT code for those who perform the procedure to place on a billing claim to receive payment from insurers, providers will not use

05 Oct

FDA Update: 2020 Biennial FDA Food Facility Registration Biennial Renewal Notification

Food companies please note The 2020 Biennial Registration Renewal Period began October 1, 2020 and concludes on December 31, 2020. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and

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