[Federal Register Volume 60, Number 191 (Tuesday, October 3, 1995)] [Notices] [Pages 51802-51803] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-24534] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Letter to Manufacturers of Blood Establishment Computer Software Products; Extension of Time Period for Premarket Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- Summary: The Food and Drug Administration (FDA) has revised the schedule for compliance with the premarket submission requirements for manufacturers of blood establishment computer software. After careful evaluation of the concerns expressed by the manufacturers, the impact of the regulatory initiative on blood establishments, and the public health significance of assuring the safety and quality of this software, FDA concluded that a 1-year extension of the time period for premarket submissions was warranted. In this notice, the agency is publishing the text of the February 10, 1995, letter sent to the manufacturers announcing a deadline of March 31, 1996, for premarket submissions. ADDRESSES: To obtain a copy of the device registration package and device listing, write to the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ-220), 5600 Fishers Lane, Rockville, MD 20857. For guidance concerning premarket submissions, write to the Center for Biologics Evaluation and Research, Division of Blood Applications (HFM-370), 1401 Rockville Pike, Rockville, MD 20852-1448. FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics Evaluation and Research (HFM-635), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-3074. SUPPLEMENTARY INFORMATION: In a March 31, 1994, letter sent to manufacturers of blood establishment computer software, FDA stated that certain software products used in the manufacture or maintenance of data for blood and blood components are devices under section 201(h) of the act (21 U.S.C. 321(h)) because these products aid in the prevention of disease by identifying unsuitable donors and by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing use. The March 31, 1994, letter stated that manufacturers would be required to make premarket submissions to CBER for each of their devices no later than March 31, 1995. The March 31, 1994, letter was published in the Federal Register of August 31, 1994 (59 FR 44991). Numerous responses from organizations representing both software manufacturers and blood establishments expressed concerns about the requirements for premarket clearances or approval and many requested additional time to comply with such requirements. After careful evaluation of the needs expressed by the software manufacturers and the impact of this regulatory initiative on blood establishments, FDA concluded that a 1-year extension to the deadline was warranted. Therefore, by letter dated February 10, 1995, FDA notified known manufacturers of blood establishment computer software products that premarket submissions should be submitted to CBER no later than March 31, 1996. The complete text of the February 10, 1995, letter follows: February 10, 1995 To: Blood Establishment Computer Software Manufacturers Dear Sir/Madam: The purpose of this letter is to notify you of the revised schedule for compliance with the various provisions of the Federal Food, Drug, and Cosmetic Act for premarket submissions for blood establishment computer software products regulated as medical devices. The schedule has been developed after careful evaluation of the concerns expressed by the software manufacturers, the impact of the regulatory initiative on blood establishments, and the public health significance of assuring the safety and quality of this software. In a letter dated March 31, 1994, the FDA stated that the agency considers software [[Page 51803]] products intended for use in the manufacture of blood and blood components or for the maintenance of data that personnel use in making decisions regarding the suitability of donors and the release of blood or blood components for transfusion of further manufacture are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Sec. 321(h)]. This initiative was also described in a Federal Register (FR) notice dated August 31, 1994 (59 44991) [copy enclosed]. As a medical device manufacturer, you are currently required under the Act to register your establishment and list your devices. In addition, your manufacturing operations are required to be in compliance with CGMP for devices, and you must report adverse events and other problems as required by FDA's Medical Device Reporting (MDR) regulations. FDA's device registration and listing regulations appear at Title 21, Code of Federal Regulations (CFR), Part 807; CGMP regulations for devices appear at 21 CFR, Part 820; and the MDR regulations appear at 21 CFR, Part 803. These and other specific points relating to establishment inspections noted in the March 31, 1994, letter and the August 31, 1994, Federal Register notice remain unchanged. In these documents, FDA stated that manufacturers of blood establishment computer software would be required to submit to the Center for Biologics Evaluation and Research (CBER) a premarket notification or application for premarket approval for each of their devices no later than March 31, 1995. The agency received numerous responses from organizations representing both software manufacturers and blood establishments. The principal concern expressed in these responses related to the requirements for premarket clearances or approval for blood establishment computer software products. The concerns included, but were not limited to, the difficulty of expeditious compliance with the requirement for premarket clearance or approval, the need for additional, detailed guidance to be used in the preparation of premarket submissions for these specific software products, and additional time needed to remove software from use by blood establishments in situations where a software manufacturer does not intend to seek premarket clearance or approval for the particular product. After careful evaluation of the needs expressed by the software manufacturers and the impact of this regulatory initiative on blood establishments, the FDA has concluded that a one year extension of the March 31, 1995, deadline is warranted. Therefore, premarket submissions should be submitted to CBER no later than March 31, 1996. The extension period for premarket submissions does not, however, affect other responsibilities of the computer software manufacturers and distributors who are subject to the device provisions of the Act and implementing regulations as previously stated. To effectively implement this important and complex regulatory program, the agency intends to work with industry to clarify the expectations concerning premarket submissions through issuance of guidance. We also plan to have a continuing dialogue with affected establishments and industry organizations. Also, within this extension period, it is the FDA's expectation that vendors and blood establishments will cooperatively conduct all transitions from software products for which premarket clearance or approval will not be sought to software products for which premarket clearance or approval is being actively pursued. These transitions should also be conducted in an orderly and effective manner so that they have minimal impact on the blood establishment's operations as they relate to the identity, safety, purity, and quality of blood products. These transitions should also be completed by March 31, 1996. If you do not intend to make a premarket submission as outlined in the August 31, 1994, Federal Register notice, this information should be promptly sent to: Center for Biologics Evaluation and Research (CBER), Division of Blood Applications (HFM-370), 1401 Rockville Pike, Rockville, MD 20852-1448. The information should include your intent to remove software from the market and identify the steps to be taken and the support to be provided during the time needed for users to efficiently transition to other products or software manufacturers by March 31, 1996. If you intend to make a premarket submission and have not done so by September 30, 1995, we request that you notify CBER by letter of the specific progress made by that point in time, the work remaining to be completed, and the anticipated date of filing each applicable premarket submission if not completed and submitted by September 30, 1995. If you have questions concerning: (1) the preparation of the establishment registration and device listing notification, contact Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ-220), at 301-443-6597, or (2) guidance for premarket submissions, contact Center for Biologics Evaluation and Research, Division of Blood Applications (HFM-370), at 301-594- 2012. Please note that information regarding the content and format for premarket notification submission can be found at 21 CFR, Part 807, Subpart E. Dated: September 26, 1995. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 95-24534 Filed 9-28-95; 11:22 am] BILLING CODE 4160-01-F