Letters, Testimony & Filings Letter to FDA Regarding Need for Renotification to Patients With the Bjork-Shiley Convexo-Concave Valve in Light of New Findings of Extremely High Failure Rates January 13, 1994
Letters, Testimony & Filings HRG Comments Regarding Premarket Approval of the Medtronic Pacer-Cardioverter-Defibrillator Control System May 5, 1993
Letters, Testimony & Filings Statement of HRG on Proposed Mandatory Device Experience Reporting Rule February 2, 1981
Letters, Testimony & Filings Comments of HRG on Proposed Procedures for Investigational Device Exemptions July 6, 1979
Letters, Testimony & Filings Letter on Food and Drug Administration (FDA) Cardiovascular Device Classification Proposals of Sidney Wolfe and Robert Leflar May 8, 1979
Letters, Testimony & Filings Comments to the Food and Drug Administration (FDA) on Proposed Procedures for Investigational Device Exemptions 21 CFR Parts 16, 20 and 812 December 14, 1978
Letters, Testimony & Filings Letter to Donald Kennedy, Food and Drug Administration (FDA) Commissioner from Leflar Notifying Him of Future HRG Oversight of FDA’s Dealings with the Medical Device Industry December 14, 1978
Letters, Testimony & Filings Summary on Proposed Investigational Device (Medical) Exemption Regulations December 5, 1978
Letters, Testimony & Filings Letter to Food and Drug Administration (FDA) Asking for Recall of Surgidev Intraocular Lenses Because of Serious Patient Injuries July 14, 1977