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U.S. Department of Health and Human Services

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FY 2001 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.
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.

Regulations
In FY2001, OHIP lawyers and paralegal staff were instrumental in allowing CDRH to:
  • meet all statutory requirements associated with implementation of the FDA Modernization Act of 1997 (FDAMA);
  • respond to 16 citizens petitions, with no overdue petitions; and
  • publish 46 Federal Register documents. Some of the most significant documents being finalized include:
Postmarket Surveillance. This final rule establishes procedures for FDA and manufacturers on the postmarket surveillance requirements. This was CDRH’s first "Plain Language" rule (see below) and it was the first rule for which CDRH is accepting comments on the Internet.
510(k) -FOI rule (Freedom of Information). We are finalizing a proposed rule to require submitters of premarket notifications to send FDA a version of the 510(k) with trade secret and confidential commercial information deleted. This rule, if implemented, would save FDA the time of deleting this information when responding to FOI requests.
States as Certifiers. FDA has finalized a rule that would transfer aspects of FDA’s role as a Certifier of mammography facilities to qualified States. The rule fully implements a provision in the Mammography Quality Standards Act (MQSA).
Mass Reclassification. CDRH issued a final rule to reclassify 28 class III devices into class II. This is a major step toward completion of the review of the pre-1976 Class III devices.
Apnea Monitors. CDRH is finalizing a 510(k) guidance document for apnea monitors and is making this guidance document a special control for these devices.
Tracking Amendments. CDRH issued a rule to implement the FDAMA amendments to the tracking provisions of the Federal Food, Drug, and Cosmetic Act.
 The regulation workload in FY2001 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
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.

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.

In FY2001, OHIP:
  • Created and updated a comprehensive database of all guidance documents issued by CDRH – currently, more than 642 guidance documents prepared under GGPs.
  • Worked with CDRH’s Office of Systems and Management to provide a searchable version of the database available on the CDRH webpage. This database can be viewed on the website to the left.
  • Updated and revised the Standard Operating Procedures (SOP) Manual for GGPs, providing CDRH authors with detailed instructions, 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.
  3. To provide advice and assistance to manufacturers in writing labeling in Plain Language.
During FY2001, OHIP:
  • Continued to sponsor plain language and writing/editing courses for CDRH staff – since these classes were first offered in FY1999, more than 325 staff have participated in classes for:
  • regulations writers,
  • letter writers,
  • support staff,
  • reviewers and non-reviewers;
  • Edited documents and webpages to assure the language used is clear and simple. Examples of these include:
  • Metal Detectors and Other Security Systems
    We edited a document about the safety of metal detectors and other security systems found in airports and building entrances. The document answers questions about safe passage through security systems by the public and by pregnant women. It also discusses the risks of electromagnetic interference with implanted medical devices such as pacemakers, implantable cardioverter defibrillators, and infusion pumps.
  • Wireless Telephones
    We collaborated with other CDRH offices and the Federal Communications Commission to design and develop a web site to provide information about wireless telephones. This web site evaluates health and safety concerns about radiofrequency energy, wireless phones, and wireless base stations.
  • 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.
  • Provided plain language review for 55 one-page summaries written by CDRH about newly approved and cleared devices which include new and emerging technologies.

FDAMA
OHIP serves as the CDRH coordinator for implementation of the FDA Modernization Act of 1997 (FDAMA). Each of the CDRH Offices is committed to implementing the provisions of FDAMA, as evidenced by a record of:
  • more than 24 final guidance documents and eight final rules;
  • three Reports to Congress;
  • routine updates to the list of recognized consensus standards;
  • implementation and proposed expansion of the Accredited Persons Review Program (discussed elsewhere in this report); and
  • implementation of the Least Burdensome provisions of FDAMA.

Throughout all of these efforts, OHIP has provided support for regulations and guidance development as well as extensive training and education for CDRH staff on FDAMA provisions. The Least Burdensome Provisions of FDAMA were the topic of CDRH’s first webcast.
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