[Federal Register Volume 63, Number 215 (Friday, November 6, 1998)]
[Notices]
[Pages 60010-60011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29752]


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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.

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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