JJ. FDA Accreditation of an
FDA received many comments (approximately 41) on this provision.
Some comments supported
These comments are the same as, or similar to, comments discussed earlier in this document; see section II.
In the proposed rule, we would have required an issuing agency to be either a private nonprofit organization or a State agency, in order to minimize potential conflicts of interest. We requested comment on the question, "Are there compelling reasons to permit a for-profit organization to be accredited as an issuing agency?" 77 FR 40736 at 40767 (Specific Question #26). Eight comments favored the requirement in proposed
We do not agree with the recommendation of the last commenter. We believe an application process with transparent criteria is preferable to a "bidding" process. We do not find the comments to be persuasive on either side of the question of accrediting for-profit organizations as issuing agencies.
We note that the international standard addressing conflicts of interest for accreditation bodies does not draw distinctions based on profit or non-profit status. ISO/IEC 17011:2004, clause 4.3.4 (Ref. 16) requires accreditation bodies to ensure that personnel and committees that could influence the accreditation process act objectively and are free from any undue commercial pressures that could compromise impartiality. We believe the potential for conflicts, whether or not related to an applicant's for-profit status, are best addressed through
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