; or (II) a subset of such articles that includes in vitro clinical tests. (2) Laboratories and blood and tissue establishments (A) Relation to laboratory certification pursuant to section 353 of the PHSA Nothing in this subchapter shall be construed to modify the authority of the Secretary with respect to laboratories or clinical laboratories under section 353 of the Public Health Service Act. (B) Avoiding duplication In implementing this subchapter, the Secretary shall avoid issuing or enforcing regulations that are duplicative of regulations under section 353. (C) Blood and tissue Nothing in this subchapter shall be construed to modify the authority of the Secretary with respect to laboratories, establishments, or other facilities to the extent they are engaged in the propagation, manufacture, or preparation, including filling, testing, labeling, packaging, and storage, of blood, blood components, human cells, tissues, or tissue products under this Act or section 351 or 361 of the Public Health Service Act. (3) Practice of medicine (A) In general Nothing in this subchapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed in vitro clinical test for any condition or disease within a health care practitioner-patient relationship pursuant to applicable Federal or State law. (B) Rules of construction (i) Sale, distribution, labeling Nothing in this paragraph shall be construed to limit the authority of the Secretary to establish or enforce restrictions on the sale, distribution, or labeling of an in vitro clinical test under this Act. (ii) Promotion of unapproved uses Nothing in this paragraph shall be construed to alter any prohibition on the promotion of unapproved uses of legally marketed in vitro clinical tests. (4) Special rule (A) Premarket review applicable Notwithstanding the exemptions from premarket review under section 587B set forth in subsections (b), (c), (d), (e), (f), (g), (h), (j), and (k) an in vitro clinical