federal_register: 2011-19733

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-19733 Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer Proposed Rule The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device pacemaker programmers. The agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of the aforementioned device based on new information. This action implements certain statutory requirements. 2011-08-04 2011 8 https://www.federalregister.gov/documents/2011/08/04/2011-19733/effective-date-of-requirement-for-premarket-approval-for-a-pacemaker-programmer https://www.govinfo.gov/content/pkg/FR-2011-08-04/pdf/2011-19733.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device pacemaker programmers. The...

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