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FDA Cracking Down on Poor Performing EUA Tests

FDA Cracking Down on Poor Performing EUA Tests

Aug 24, 2020 | News

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or...
The Final Guidance: FDA on Multiple Function Device Products

The Final Guidance: FDA on Multiple Function Device Products

Aug 15, 2020 | News

On July 28th, the FDA issued the final guidance pertaining to multiple function device products (MFDPs). Products may include several functions and the FDA is now in the process of accommodating for such devices, which can get complicated. MFDPs are products with one...
Harmonization of the Quality System Regulation

Harmonization of the Quality System Regulation

Aug 7, 2020 | News

In May 2018, the FDA first proposed revising its current Quality System Regulation (QSReg) to better align with ISO 13485:2016. The QSReg is the foundation rule for manufacturing safe and effective medical devices to be sold in the US, while ISO 13485 forms the basis...
FDA Restarting Domestic Inspections

FDA Restarting Domestic Inspections

Aug 6, 2020 | News, Services

On July 10, 2020, the U.S. Food and Drug Administration (FDA) stated their plan on restarting onsite domestic inspections. In March, FDA had reduced inspections due to the COVID-19 pandemic, and they have only been conducting mission critical inspections over this...
Electronic Submissions For Medical Devices

Electronic Submissions For Medical Devices

Aug 3, 2020 | Documents, News

On July 15, 2020, FDA released a guidance regarding electronic submissions for medical devices as well as the FDA’s plans for implementing section 745A(b)(3) of the FDA Reauthorization Act of 2017 (FDARA). The FDA has stated that additional details will be laid out in...

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IVDR: What You Need to Know about Europe’s Changing IVD Market

The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements. Under this directive, all products of all classes that stay on the market after May 26, 2022 must be reassessed for IVDR compliance to ensure that those products are fit for purpose and safe to use. There is no automatic pass granted based on the...
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FDA Cracking Down on Poor Performing EUA Tests

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological or nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives.” Since February 4, 2020, FDA has approved 204 Covid-19 tests...
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The Final Guidance: FDA on Multiple Function Device Products

On July 28th, the FDA issued the final guidance pertaining to multiple function device products (MFDPs). Products may include several functions and the FDA is now in the process of accommodating for such devices, which can get complicated. MFDPs are products with one device function and at least one “other function,” which may or may not be considered a medical device—for example, a product has an additional software function like patient management. The term “software,” as it relates to a...
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