Regulatory

Regulatory

Contributors in Regulatory

Regulatory

"Correction" means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product and/or the promotional materials which cause the product to be ...

default decree

Life Sciences; Regulatory

A Default Decree of Condemnation is a Court Order entered when lots under seizure are not claimed or defended. The order condemns the product as being in violation and provides for destruction, ...

de minimus

Life Sciences; Regulatory

de minimus, not enough to be considered, to be taken into account

deposition

Life Sciences; Regulatory

The sworn testimony of a witness obtained outside the courtroom before trial through examination and cross-examination by the attorneys for the parties.

detention

Life Sciences; Regulatory

Administrative act whereby FDA requires that imported articles which appear violative under the laws FDA administers be held intact. Detained articles may be released if brought into compliance with ...

instructions for use

Biotechnology; Biochemistry

"a manual usually accompanying a technical device and explaining how to install or operate it" Essential Requirements - Medical Device Directive 93/42/EEC - Annex I, 13.1: Each device must be ...