Latest Updates on Regulatory

Written by: Andrey Grishin, MD, Globiox Consultant With the recognition by the US Food and Drug Administration (FDA) of last country-member Slovakia just a few weeks ago, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective

Almost There: Safety and Performance Pathway Option for 510(k) Submissions

Written by: Daniel Miranda, Globiox Consultant On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for 510(k) submissions. This pathway gives another option for medical devices that have technological differences but that are still as safe and effective as a legally marketed predicate device. Typically, in these situations, the

FDA plans major overhaul, looks to be more specialized

5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency would need to realign its programs. With very little detail it was revealed that it would be led by a Program Alignment Group (PAG) consisting of all executive-level members of each of

The FDA’s “dos” and “don’ts” for responding to a 483

DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to observations that are noted as being repeated from previous inspections. If you have not remediated a previous observation, it may be that you did not understand what the FDA meant. Ask!  If

High frequency of CAPA related observations in warning letters

Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating

Don’t let the user manual become the user

Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software. Sounds pretty straight forward, right? But when we look at the customer’s user requirements documents, we realized that they were derived from user manuals and specification sheets that manufacturers provide for

Combined use diagnostic instruments and the FDA’s thoughts

The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to mitigate interference in molecular diagnostic instruments with combined FDA approved device functions and functions in which FDA approval is not required, and furthermore prevent confusion for the end user. While following the guideline should serve

Warning Letters: What they are, How we can help

As discussed in our previous post, “FDA 483: your company contains critical errors,” a company whose operations are not compliant with the regulations set out by the Federal Food, Drug, and Cosmetic Act and related acts (The Act) is likely to face serious consequences from the FDA. Although there are exceptions in the case of

FDA 483: Does your business contain critical errors?

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products,