ABSTRACT
If a m anufacturer engages in on ly som e opera tions sub ject to the requ ire m ents in this part, and not in others, that m anufacturer need on ly c om p ly w ith th ose requ irem ents app licab le to the opera tions in w h ich it is engaged. W ith re sp ect to class I d ev ices , design con tro ls app ly on ly to th ose d ev ices listed in Sec. 820.30 (a)(2 ). Th is regulation does not app ly to m anufacturers o f com po nents or parts o f finished d ev ices , but such m anufacturers are encou raged to use appropria te p rovis ions o f this regu lation as gu idance. M anufacturers o f hu man b lood and b lood com ponen ts are not sub ject to this part, but are subject to part 606 o f this chapter.
