Life is a Journey..how to make the best of it!

BayBiotech.NET A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request. As per FDA definition, these are the definition of Summary and Statements: Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant. 510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has be

BayBiotech.NET Protected Health Information or individually identifiable health information relates to the data about demographics, individual’s past, present or future physical or mental health or condition, provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual. Individually identifiable health information includes many common identifiers such as name, address, birth date and social security number. A covered entity (health plan, a health care clearinghouse, or a health care provider) must obtain the individual’s written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule. Principle of “Minimum Necessary” Use and Disclosure Principle of “Minimum Necessary” is the central aspect of the privacy rule. Under this principle, it is expected that a reasonable effort mu