[Federal Register: November 6, 1998 (Volume 63, Number 215)] [Notices] [Page 60010-60011] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06no98-86] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98D-0896] Guidances for the Medical Device Industry on PMA Shell Development and Modular Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidances for the Medical Device Industry on PMA Shell Development and Modular Review.'' This guidance describes a new program for the submission and review of premarket approval applications (PMA's) in a modular format, termed the ``PMA Shell.'' FDA is issuing this document as part of its commitment to improve the PMA development and review processes. DATES: Written comments concerning this guidance must be received by February 4, 1999. ADDRESSES: Submit written requests for single copies of the guidance document entitled ``Guidances for the Medical Device Industry on PMA Shell Development and Modular Review'' (on a 3.5'' diskette) to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments on this guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ashley A. Boulware or Kathy M. Poneleit, Center for Devices and Radiological Health (HFZ-460 or HFZ- 402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053 or 301-594-2186. SUPPLEMENTARY INFORMATION: I. Background Despite a marked improvement in device approval times, FDA's Center for Devices and Radiological health (CDRH) is committed to substantial improvement of the PMA development and review processes. Often FDA's involvement with the product has been greatest during review of the PMA, which is at the end of the process. This new program involves the development of a plan for modular submission, termed the ``PMA Shell,'' and the submission of sections of the PMA, termed modules, to increase early and effective interactions with applicants. The essence of the modular concept for data development, submission, review, and closure is to break the contents of a PMA into well delineated components (modules) that can be submitted over time; this is expected to be particularly applicable to the preclinical information as the clinical data are being developed. The PMA Shell is a document that is proposed by the potential PMA applicant and agreed to by CDRH. The PMA Shell is used to identify the proposed modules and the proposed contents for each module. The PMA Shell allows CDRH to prospectively determine whether each proposed module will be appropriate as a document that can be reviewed separately from other information needed to evaluate the PMA. For example, the toxicology data may be appropriate as a module, whereas labeling may not be appropriate as a module independent of the clinical study data. Modules will be submitted to CDRH for review. Once they are complete and acceptable to FDA, modules will not generally be reevaluated unless a significant safety and effectiveness issue later develops that bears on the previously reviewed module. Through increased interaction with applicants and earlier review of data and analyses, CDRH expects this program to increase the efficiency of PMA review by reviewing and bringing to closure modules nearer to when the data are developed and when the corporate staff who developed the data should most easily be able to respond to any need for clarification of the reports. II. Significance of Guidance This guidance document represents the agency's current thinking on improving the PMA process. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfied the applicable statute, regulations, or both. The agency has adopted Good Guidance Practices (GGP's), which set forth the agency's policies and procedures for the development, issuance, and use of guidance documents (62 FR 8961, February 27, 1997). This guidance document is issued as a Level 1 guidance consistent with GGP's. III. Comments Interested persons may, on or before February 4, 1999, submit to the Dockets Management Branch (address above) written comments regarding this guidance. After February 4, 1999, submit written comments regarding this guidance to the contact persons (address above). Such comments will be considered when determining whether to amend the current guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access In order to receive ``Guidances for the Medical Device Industry on PMA Shell Development and Modular Review'' via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At the first voice prompt press 1 to access DSMA Facts, at second voice prompt press 2, and then enter the document number (835) followed by the pound sign (#). Then follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so using the World Wide Web (WWW). CDRH maintains an entry on the WWW for easy access to information including text, graphics, and files that may be downloaded to a personal computer with access to the Web. Updated on a regular basis, the CDRH home page includes ``Guidances for the Medical Device Industry on PMA Shell Development and Modular Review,'' device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, mammography matters, and other device-oriented information. [[Page 60011]] The CDRH home page may be accessed at ``http://www.fed.gov/cdrh''. ``Guidances for the Medical Device Industry on PMA Shell Development and Modular Review'' will be available at ``http://www.fda.gov/cdrh/ ode''. Dated: October 28, 1998. D.B. Burlington, Director, Center for Devices and Radiological Health [FR Doc. 98-29752 Filed 11-5-98; 8:45 am] BILLING CODE 4160-01-F