AccuReg - The Regulatory Forum: Quiz 10

QUIZ#10: DESIGN CONTROL REGULATIONS

Evaluate whether each of the statements below is TRUE or FALSE.

A number of Class I devices containing software have been exempted from Design Control requirements.
Design controls are applicable to Engineering and R&D, but do not involve Management.
There is no one "right way" to implement design controls.
The Design Plan is a required document, per 21 CFR Part 820.30.
Once the Design Plan has been established, it should not be modified during the product development process.
An SOP entitled, "Design Inputs" is an absolute requirement of 21 CFR 820.30.
Design Input documents do not include informal concept documents (such as marketing memoranda), although these may serve as inputs to a CRS, PRS, etc.
Generally, an item is Design Output if it is a work product of a design task listed in the Design Plan, and defines, describes or elaborates an element of the design implementation.
Any individual without direct responsibility for the design stage being reviewed should not be present at a design review meeting.
Design verification activities can vary widely, and may be static or dynamic.
Design review is always considered to be a design verification activity.
FDA defines Design Change as encompassing both manufacturing change control (changes to the product itself or its production methods) and document control (changes to the documents that define the product and processes)
Design Validation does not necessarily include testing.

How did you do? After you have taken the Quiz, request the answers for Quiz #10 via e-mail from accureg@regulatory.com. If you include your address, we'll send you a pocket book of the GMPs for Medical Devices (21 CFR Part 820) or for Finished Pharmaceuticals (21 CFR Part 211). Please be sure to specify which regulation you would prefer.

Return to The Regulatory Forum

7501 Northwest 4 Street, Suite 210
Plantation, Florida 33317, USA
Telephone: 954-641-6400 Fax: 954-641-6410
Email: accureg@regulatory.com

Contact webmaster