Regulations

In FY2000, 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 20 citizens petitions, with no overdue petitions; and

• publish 100 Federal Register documents. Some of the most significant documents included:

• Postmarket Surveillance. This proposed rule would establish 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 published 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. This proposed rule 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).
• Lay Summaries. CDRH issued a final rule to require mammography facilities to send patients "lay summaries" explaining the results of their examination. This rule implemented a provision of the Mammography Quality Standards Reauthorization Act.
• The "Six Year" Rule. CDRH issued final guidance on implementation of section 216 of FDAMA. This section allows FDA to use data from Premarket Approval (PMA) applications approved more than six years earlier when approving or reclassifying devices.
• 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 withdrew its proposal to require a mandatory standard for apnea monitors. Instead, CDRH issued a draft 510(k) guidance document for apnea monitors and proposed to make this guidance document a special control for these devices.
• Tracking Amendments. CDRH issued a proposed rule to implement the CDRH amendments to the tracking provisions of the Federal Food, Drug, and Cosmetic Act.

The regulation workload in FY2000 was consistent with that of previous years. The number of staff assigned to the regulation process has steadily decreased. However, 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.

In FY2000, OHIP:

• Worked with the GGP coordinators across FDA to develop a regulation on GGPs that was published on September 19, 2000. A refresher course was given to update all staff on the revised procedures and changes resulting from the final regulation.
• Created and updated a comprehensive database of all guidance documents issued by CDRH – currently, more than 607 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.
• 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 as well as quarterly updates.

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.

• continued to sponsor plain language and writing/editing courses for CDRH staff – since these classes were first offered in FY1999, more than 250 staff have participated in classes for

• regulations writers,
• letter writers,
• support staff,
• reviewers and non-reviewers;

• worked with CDRH’s Office of Surveillance and Biometrics to issue CDRH’s first proposed rule written in plain language; and,
• 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.

FDAMA

• 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.