Profile

Best practice includes early communication and negotiation about requirements at a high level. First the Marketing function may say where are the target markets and the Design function may suggest the product concept. Then the Regulatory function can evaluate relevant regulations and extract some hard ...

The FDA compliance dashboards are a useful resource to begin the search. https://datadashboard.fda.gov/ora/cd/index.htm Go to inspections and search your company name and you may find some history. ------------------------------ Anne LeBlanc United States ------------------------------

Hello Anon Assuming GS1 is your issuing agency, they'll provide you a block of GTINs and you'll assign a GTIN to each of your product models to serve as the UDI-DI. The UDI-PI will be made of all the production identifiers you use on your labels. Here's a sample: The number following the (01) ...

Hi Anon There are several exclusions described in Article 2, Scope, that might apply to your product, depending on the details. For example, the directive doesn't apply to "equipment specifically designed solely for the purposes of research and development only made available on a business-to-business ...

And note that this changes under the QMSR: (Comment 55) FDA received numerous comments regarding the lack of an exception for management review, quality audits, and supplier audit reports, which formerly existed in the QS regulation, at § 820.180(c). Most such comments requested that FDA maintain the ...