Rosina Robinson, RN, MEd, RAC - Comment

It is important to note that this proposal relates solely to information made to the general public that may by coincidence only include members of the regulated industry and health care professionals. Of greatest concern to me are the following issues: 1. Some of the proposals would provide the public with information which may or may not be meaningful or useful because of lack of understanding in the applicable regulatory process. 2. The proposals only specify use of electronic media without consideration of information availability to that segment of the population without access to computers. 3. The Agency's disclosure of regulatory information has limited usefulness to the general public or even the medical community who have limited understanding or even a misunderstanding of the statutory and regulatory requirements for medical devices and other FDA-regulated products. 4. If many of the proposals are implemented, medical device manufacturers would face increased product liability exposure since even without the proposed disclaimers might be interpreted as "proof" of wrongdoing. 5. While some of the increased disclosure and transparency about applications, adverse events, etc. would be meaningful to members of the medical device industry, the additional costs related to increasing transparency would be better spent on Phase 3 of the initiative that will be intended to provide information to the industry. 6. The disclosure of information about applications under Agency review including reasons for such communication does not serve the public interest. It is unclear how the public would use this information because they are unaware that many applications are subject to requests for additional information that is submitted shortly thereafter or in a resubmission.