News from the FDA

Guidance Discusses Bundling Device Submissions

A recently released guidance titled “Bundling Multiple Devices or Multiple Submissions in a Single Submission” is intended to answer frequently asked questions about the FDA's policy on bundling multiple devices or multiple indications in a single premarket submission. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the bundling policy takes on additional importance because of the fees that are now associated with certain submissions as well as the performance goals the agency has committed to meet. The guidance is being issued as final for immediate implementation. A copy of the guidance document may be obtained at the Center for Devices and Radiological Health (CDRH) Web site at http://www.fda.gov/cdrh/.

Drugs of Abuse Screening Tests: Draft Guidance Available

The FDA announces the availability of the “Draft Guidance for Industry and FDA Staff; Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests.” This draft guidance will assist industry in preparing premarket notification submissions for drugs of abuse screening tests. The draft guidance also provides recommendations regarding the labeling of these tests. This draft guidance is neither final nor in effect at this time. Written or electronic comments on this guidance will be accepted until March 1, 2004. For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29855.htm.

Expedited Review of Premarket Submissions

“Expedited Review of Premarket Submissions for Devices,” a guidance that was released in late 2003 and is now in effect, sets out the criteria for granting expedited review, and outlines the procedures that should be followed in the review process. Expedited review is available on devices used to treat or diagnose an irreversibly debilitating or life-threatening diseases for which there is an unmet need. It supersedes and replaces a 1998 guidance document and explains the procedures that the FDA intends to use to review and track expedited PMA applications against the MDUFMA performance goals when the PMA applicant meets the additional criteria. The new guidance also explains the procedures that the FDA plans to use to expedite the review of PDPs, 510(k)s, and de novo classification actions. For further information, go to: http:/ /a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29463.ht 

Dental Devices: Designation of Special Controls

On its own initiative, the FDA has proposed amending the classification regulations of gold-based alloys and precious metal alloys for clinical use and base metal alloy devices. The agency is also proposing to exempt these devices from premarket notification and designate a special control for them. Any final regulation that may issue based on this proposal will become effective 30 days after its date of publication in the Federal Register. Following the effective date, any firm claiming exemption from the premarket notification requirements for a dental precious metal or base metal alloy covered by the rule will need to address the issues covered in the appropriate special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

The guidance documents that would serve as special controls for these devices — “Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys” and “Class II Special Controls Guidance Document: Dental Base Metal Alloys” — can be found at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets. For more details, see a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29740.htm.

FDA Wants to Raise Maximum Penalty Amounts

The FDA is proposing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within its jurisdiction. For example, the maximum penalty for violation of certain requirements of the Prescription Drug Marketing Act (PMDA) would increase from $50,000 to $55,000, while other violations of the PMDA would garner a maximum penalty of $1,100,000, as opposed to the previous high of $1,000,000. Violations of certain other regulations, such as the Mammography Quality Standards Act of 1998, would not rise under the proposed penalty scheme. In cases in which an upward adjustment is proposed, the adjusted civil monetary penalty is subject to the Federal Civil Penalties Inflation Adjustment Act of 1990's provision restricting the initial adjustment to no more than 10%.

Submit written comments on the proposal by Feb. 17, 2004 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecom ments. To see the list of proposed changes, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29741.htm.

Guidance Discusses Bundling Device Submissions

A recently released guidance titled “Bundling Multiple Devices or Multiple Submissions in a Single Submission” is intended to answer frequently asked questions about the FDA's policy on bundling multiple devices or multiple indications in a single premarket submission. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the bundling policy takes on additional importance because of the fees that are now associated with certain submissions as well as the performance goals the agency has committed to meet. The guidance is being issued as final for immediate implementation. A copy of the guidance document may be obtained at the Center for Devices and Radiological Health (CDRH) Web site at http://www.fda.gov/cdrh/.

Drugs of Abuse Screening Tests: Draft Guidance Available

The FDA announces the availability of the “Draft Guidance for Industry and FDA Staff; Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests.” This draft guidance will assist industry in preparing premarket notification submissions for drugs of abuse screening tests. The draft guidance also provides recommendations regarding the labeling of these tests. This draft guidance is neither final nor in effect at this time. Written or electronic comments on this guidance will be accepted until March 1, 2004. For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29855.htm.

Expedited Review of Premarket Submissions

“Expedited Review of Premarket Submissions for Devices,” a guidance that was released in late 2003 and is now in effect, sets out the criteria for granting expedited review, and outlines the procedures that should be followed in the review process. Expedited review is available on devices used to treat or diagnose an irreversibly debilitating or life-threatening diseases for which there is an unmet need. It supersedes and replaces a 1998 guidance document and explains the procedures that the FDA intends to use to review and track expedited PMA applications against the MDUFMA performance goals when the PMA applicant meets the additional criteria. The new guidance also explains the procedures that the FDA plans to use to expedite the review of PDPs, 510(k)s, and de novo classification actions. For further information, go to: http:/ /a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29463.ht 

Dental Devices: Designation of Special Controls

On its own initiative, the FDA has proposed amending the classification regulations of gold-based alloys and precious metal alloys for clinical use and base metal alloy devices. The agency is also proposing to exempt these devices from premarket notification and designate a special control for them. Any final regulation that may issue based on this proposal will become effective 30 days after its date of publication in the Federal Register. Following the effective date, any firm claiming exemption from the premarket notification requirements for a dental precious metal or base metal alloy covered by the rule will need to address the issues covered in the appropriate special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

The guidance documents that would serve as special controls for these devices — “Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Dental Precious Metal Alloys” and “Class II Special Controls Guidance Document: Dental Base Metal Alloys” — can be found at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets. For more details, see a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29740.htm.

FDA Wants to Raise Maximum Penalty Amounts

The FDA is proposing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within its jurisdiction. For example, the maximum penalty for violation of certain requirements of the Prescription Drug Marketing Act (PMDA) would increase from $50,000 to $55,000, while other violations of the PMDA would garner a maximum penalty of $1,100,000, as opposed to the previous high of $1,000,000. Violations of certain other regulations, such as the Mammography Quality Standards Act of 1998, would not rise under the proposed penalty scheme. In cases in which an upward adjustment is proposed, the adjusted civil monetary penalty is subject to the Federal Civil Penalties Inflation Adjustment Act of 1990's provision restricting the initial adjustment to no more than 10%.

Submit written comments on the proposal by Feb. 17, 2004 to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecom ments. To see the list of proposed changes, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-29741.htm.