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U.S. Department of Health and Human Services

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FY 2003 OHIP Annual Report - Regulations and Guidance

OHIP plays an essential role in the development of all CDRH regulations and Federal Register documents, as well as in the management of Good Guidance Practices.

 Regulations

Goals

  1. To manage all aspects of CDRH's regulations development process.
  2. To serve as regulatory experts on CDRH teams addressing medical device or radiological health issues.
  3. To coordinate the development, review, and submission of all Federal Register publications for CDRH, including citizen petitions.

In FY 2003, OHIP lawyers and paralegal staff were instrumental in allowing CDRH to:

  • meet all statutory requirements associated with implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA);
  • respond to 11 citizens petitions, with no overdue petitions; and
  • publish 61 Federal Register documents. Some of the most significant documents include:
  • Patient Examination and Surgeons’ Gloves. This proposed rule would establish new test procedures and acceptance criteria for leakage testing of patient examination and surgeons’ gloves. It would also tighten the criteria to conform to international practices and to assure the quality of gloves .
  • Performance Standard for Diagnostic X-Ray Systems and their Major Components. This proposed rule would update the standard to account for changes in technology and use of radiographic and fluoroscopic systems as well as to fully utilize the currently accepted metric system of units in the standard.
  • Reprocessed Single-Use Devices: Submission of Validation Data. In accordance with MDUFMA, this notice listed the critical reprocessed single-use devices for which FDA was terminating an exemption from the 510(k) requirements and for which reprocessors needed to submit validation data. FDA also made available a guidance document to assist in the submission of validation data.
  • Classification of Human Dura Mater. CDRH issued a proposed rule to classify human dura mater into class II (special controls). At the same time, CDRH made available a draft guidance document that would serve as the special control for the device, once it is classified.
The regulation workload in FY 2003 was consistent with that of previous years. In order to maintain a high level of output and quality, OHIP continued to implement improvements and changes identified through CDRH-wide reengineering of the regulation process.

Good Guidance Practices
Good Guidance Practices (GGPs) are FDA’s policies and procedures for developing and issuing guidance documents. Guidance documents describe FDA’s interpretation of, or policy on, a regulatory issue. They are typically prepared for FDA staff, applicants/sponsors and/or the public. The GGP policy standardizes the development process for guidance documents, provides opportunities for public comment, and clarifies the use of guidance documents. Each FDA Center is charged with implementing its own GGPs. OHIP leads implementation, administration, and monitoring of GGPs within CDRH.

Goals

  1. To provide coordination and leadership for CDRH's GGP process.
  2. To work with CDRH's Office and Division GGP contacts to ensure that CDRH guidance documents comply with the GGP regulation.
  3. To assure easy access to CDRH guidance documents over the Internet.

In FY 2003, OHIP:

  • Updated and maintained a comprehensive database of all guidance documents issued by CDRH – currently, more than 778 guidance documents prepared under GGPs.
  • Published 53 notices of availability for guidance documents.
  • Updated and revised the Standard Operating Procedures (SOP) Manual for GGPs, including templates and checklists.
  • Worked with CDRH’s GGP contacts to publish an annual listing of all guidance documents.

Plain Language

On June 1, 1998, the President issued a directive that the federal government's writing must be in plain language. Basically, plain language means that our documents must be clear and easy to read.

Within CDRH, OHIP is responsible for coordinating the implementation of plain language in all of our written communications, including regulations and guidance documents.

Goals

  1. To assure that CDRH's written communications are clear and easy to read.
  2. To provide advice and assistance to CDRH staff on writing in Plain Language.

During FY 2003, OHIP:

  • Continued to assure that new CDRH documents are written in plain language and that plain language is incorporated into existing CDRH documents as they are updated and revised.
  • Edited documents and webpages to assure the language used is clear and simple.
  • Provided plain language review for 30 one-page summaries written by CDRH about newly approved and cleared devices which include new and emerging technologies.
  • Continued to sponsor plain language and writing/editing courses for CDRH staff.
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