provides: (d)(1) After FDA approves a PMA, any change described in paragraph (d)(2) of this section that enhances the safety of the device or the safety in the use of the device may be placed into effect by the applicant prior to the receipt under S 814.17 of a written FDA order approving the PMA supplement ... (2) The following changes are permitted by paragraph (d)(1) of this section: (i) Labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction. (ii) Labeling changes that add or strengthen an instruction that is intended to enhance the safe use of the device. (iii) Labeling changes that delete misleading, false, or unsupported indications. (iv) Changes in quality controls or manufacturing process tha h Cir.1999) (<HOLDING>). STEIN, J., dissenting. Underlying this appeal
holding that substantive review is adequate holding that pma process is not specific requirement because of lack of substantive prerequisites for approval recognizing  1983 substantive due process claim holding that this lack of any reasonable expectation of continued employment suffices to establish the lack of property in the constitutional sense and hence the lack of a viable due process claim holding that pma process is not specific regulation because the requirements are not contained in formal regulation