Reading Room

To help the community with finding their way through the regulations and guidances, we include links to many we have found useful here:

FDA database

FDAlytics has sponsored our company’s ability to prepare for audits and FDA readiness activities by providing our team with access to a clone of FDA’s databases of 483, Inspectional Observations, Establishment Inspection Reports, Warning Letters, and historical data on FDA employees and FDA registered companies. We promote the use of their tools and support their development and continuous improvement. We are grateful to have FDAlytics as a partner! Please inquire with us if your organization is interested in exploring their tools.

FDA’s work instructions and standard operating procedures start here

FDA's Investigations Operations Manual contains the work instructions and standard operating procedures used by US Food and Drug Administration employees. Even after working for FDA, our team uses sections of this manual to ensure the work we perform is parallel to how FDA would have their own employees doing these activities.

Preparing for Drug Inspections

FDA's Compliance Program Guidance Manual for Drug Pre-Approval Inspections is used by Investigators preparing to perform pre-approval inspections of drug and biologics products. We point attention to this guidance, because it discusses what an Investigator is being sent to a facility to review as part of performing a pre-approval inspection for a drug or biologic product.

FDA’s Compliance Program Guidance Manual for Drug Manufacturing Inspections is also used by Investigators preparing to perform inspections of drug and biologics products manufacturing. This guidance discusses what an Investigator is sent to a facility to review as part of several types of inspectional assignments issued from FDA’s work plan.

preparing for medical device inspections

FDA's Compliance Program Guidance Manual for Inspection of Medical Device Manufacturers is used by Investigators preparing to perform an inspection of a medical device manufacturer. We use this guidance regularly in supporting many medical device and combination product manufacturers in their design, development, and eventual approval.

As part of preparing for inspections, FDA Investigators check the registration status and the products listed under the facility in which they are preparing to inspect. For medical device manufacturers, this database of registered companies is public, and verification of registration of companies can be performed by searching for the entity here.

Another tool used by FDA Investigators when preparing to perform an inspection of a medical device manufacturer is here. Investigators review adverse events reported for a facility prior to visiting the site. FDA’s centers use these reports to prioritize FDA’s work plan of companies.

Interfacing with notified bodies and CE marking

European Commission's Medical Device Regulations were published in 2017 and are still in transition of enforcement. As our team has been largely operating in the European Market, we have been working with these regulations to assists companies from their transition of accreditation under MDD regulations to the MDR regulations.

European Commission's In-Vitro Diagnostic Regulations were also published in 2017. Products which have been cleared under the older regulations are also under scope of what is required to transition to the new IVDR regulations prior to cut off dates.