definiens: means any and all applicable common law, statutes, ordinances, rules, regulations, codes, requirements, laws or orders of any agencies, commissions, officials, courts and other governmental and regulatory authorities and instrumentalities of the United States governing : ( i ) marketing approval or clearance, testing, investigation, design, manufacture, packaging, labeling, handling, storage, distribution, installation, servicing, marketing, or sale, ( ii ) recordkeeping and reporting obligations, ( iii ) recalls, or ( iv ) similar regulatory matters, with respect to the Services provided and/or the products to which the Services relate . Applicable Laws shall include, without limitation, ( a ) if the Services involve the design, manufacture, packaging, labeling, storage, installation, or servicing of a medical device or accessory that is suitable for use or capable of functioning ( whether or not it is packaged, labeled, or sterilized ), current good manufacturing practices as specified in the FDA 's Quality System Regulation at 21 CFR Part 820, including but not limited to the Design Controls requirements at 21 CFR Part 820, Subpart C, ( b ) the Clinical Laboratories Improvement Act and regulations promulgated thereunder, 42 U.S.C. 263a and 42 CFR Part 493, and ( c ) any similar regulatory requirements, as such regulatory requirements are in effect at the time the Services are provided, and as such regulations and similar regulatory requirements are interpreted at the time