Document issued on: November 10, 2005
This document supersedes “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff,” dated July 6, 2004.
For questions regarding this guidance, contact Harry R. Sauberman, P.E. at (301) 443-8879 or by email firstname.lastname@example.org or Kenneth J. Cavanaugh Jr., Ph.D. at (301) 443-8517 x170 or by email email@example.com.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Table of Contents
- THE LEAST BURDENSOME APPROACH
- PROCEDURAL QUESTIONS AND ANSWERS
- ADMINISTRATIVE CONSIDERATIONS
- THE BASIC PREMARKET SUBMISSION USING THE STED HARMONIZED FORMAT
- HOW DO I SUBMIT A 510(k) USING THE “DRAFT STED DOCUMENT”?
- HOW DO I SUBMIT A PMA USING THE “DRAFT STED DOCUMENT”?
Contains Nonbinding Recommendations
Comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
When submitting comments, please refer to Docket No. 01D-0281. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1347 to identify the guidance you are requesting.
Guidance for Industry and FDA Staff
A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
This guidance extends the voluntary pilot premarket review program, Summary Technical Documentation (STED pilot), until we have received an adequate number of submissions to evaluate the STED pilot. The guidance was originally issued, with publication in the Federal Register, on June 26, 2003 (68 FR 38068). A July 6, 2004, revision published in the Federal Register on July 23, 2004 (69 FR 44040). It is intended to assist the medical device industry and Food and Drug Administration (FDA) staff in implementing a voluntary pilot premarket review program that may reduce the burden on manufacturers who face conflicting premarket submission format and content requirements in different countries. The proposed pilot program will evaluate the utility of an alternative procedure for device premarket submissions.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
FDA is conducting a voluntary pilot premarket review program and is soliciting participation from the medical device industry. The STED pilot will be implemented by FDA's Center for Devices and Radiological Health (CDRH). It is intended to assess the feasibility of a proposed internationally harmonized format and content for receiving premarket approval (PMA) applications and 510(k) premarket notification submissions. The proposed harmonized format and content is described in the document entitled, “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices,” otherwise known as the “draft STED document.” The document was developed by Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF) and issued as a proposed document on October 25, 2002.
This STED Pilot is limited to PMA applications and 510(k) submissions. Examples of the types of medical devices that may be considered in the pilot are identified in Table 1 of this document. This listing should not be considered all-inclusive. Devices for which there is a common and substantial interest by the member countries of GHTF may be considered within the scope of this initiative.
The agency encourages manufacturers who intend to submit PMA applications or 510(k) premarket notifications to participate in the pilot program. During the pilot, the “draft STED document,” when used in conjunction with this guidance, will serve as an alternative to the submission procedures described in previous FDA guidance documents.
FDA supports the work of GHTF through its U.S. membership. A major objective of GHTF is harmonization of regulatory systems to reduce the regulatory burden on regulated industry. The GHTF believes that achieving this objective will bring added efficiency to the device review process. Devices that can be subject to harmonized reviews can, it is believed, be available more quickly to the international community.
The GHTF is a voluntary international group. It is comprised of device regulatory officials and industry representatives from the five founding members. These include the United States, Canada, Australia, the European Union, and Japan. Each of the member countries has agreed to participate in the pilot program. Each will provide specific directions for implementing the program within their respective jurisdictions. At the end of the pilot, the GHTF will assess the international benefit of the “draft STED document.”
SG1 is the premarket evaluation study group under the GHTF umbrella. The study group encourages manufacturers to prepare submissions using the "draft STED document," for a particular device, to as many of the participating GHTF countries as possible. SG1 also encourages manufacturers to use the "draft STED document" for submissions that cover a range of devices having different regulatory classes. Candidate devices that have already been identified to be of mutual interest to the GHTF members are listed in Table 1.
FDA intends to process premarket submissions that have been prepared in the format described in the “draft STED document” (STED harmonized format) within statutory time limits. Review times will be comparable to those of other submissions for similar products. There will be no expedited review of submissions, unless the device under review merits such treatment based on existing procedures and policies.
With the issuance of this guidance, FDA plans to keep the pilot program active until we have received an adequate number of submissions to evaluate the program. The pilot program began on June 26, 2003. This is the date the guidance was announced in the Federal Register. During its now extended course, FDA will assess how well the pilot is proceeding. At the end of each year of the pilot, FDA and the other GHTF participants will analyze the entire program to determine if the STED harmonized format is a viable alternative to current premarket submission formats and whether the program should be continued or expanded. FDA’s and GHTF’s analyses of their respective pilot programs will include an assessment of: (1) whether there are significant impediments to filing and review of documents; (2) whether the STED harmonized format has utility for evaluating different regulatory classes of devices having different complexities; and, (3) whether use of the STED harmonized format results in improved regulatory review times.
FDA will post a report summarizing the results of its analysis of the pilot on its Internet web site following the outcome of the pilot program. The GHTF secretariat and the SG1 Chair may post additional information regarding the pilot program on their respective web sites.
Additional information concerning GHTF's organizational structure, goals, and procedures are available on the GHTF Internet web site.
III. THE LEAST BURDENSOME APPROACH
We believe we have chosen, in this guidance document, the least burdensome approach towards meeting device premarket submission requirements and related procedural concerns. The “draft STED document” presents an alternative path for submitting PMA applications or 510(k) premarket notifications. If, however, you believe there is a less burdensome way to proceed, you should follow the procedures outlined in “A Suggested Approach to Resolving Least Burdensome Issues".
This guidance on the subject of the STED harmonized format supplements the GHTF “draft STED document” as follows:
- It provides administrative information and guidance to device manufacturers who are considering using the “draft STED document” to submit a PMA application or a 510(k) premarket notification in a harmonized format.
- It describes the extent to which harmonized documentation identified in the “draft STED document” may need to be supplemented by additional data and/or information to assure compliance with U.S. requirements.
V. PROCEDURAL QUESTIONS AND ANSWERS
What specific guidance documents should a manufacturer have on-hand to assist in preparing a premarket submission in accordance with the STED harmonized format?
In addition to this final guidance, a manufacturer contemplating a PMA application or a 510(k) submission in the format described in the “draft STED document” should have the following five key documents:
- The letter to the global medical device industry announcing the proposed pilot premarket program
- The “draft STED document” which describes the internationally harmonized format and content for premarket submissions, e.g., PMA applications and 510(k) submissions, based on conformity to GHTF's “Essential Principles of Safety and Performance of Medical Devices”.
- The GHTF document entitled: “Essential Principles of Safety and Performance of Medical Devices” (Essential Principles), which lists general and specific safety and performance recommendations for medical devices.
- The document entitled: “The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry,” October 2002.
- CDRH’s Device Advice.
Which FDA offices will participate in the pilot premarket program?
The STED pilot program will be implemented by the Office of Device Evaluation (ODE) within FDA's Center for Devices and Radiological Health. During the pilot, ODE will have responsibility for reviewing and evaluating premarket submissions using the STED harmonized format. Other offices within the Center will assist ODE as necessary by providing consultation and document review as appropriate.
Within ODE, four divisions will participate in the program. These are:
- Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID)
- Division of Reproductive, Abdominal, and Radiological Devices (DRARD)
- Division of Cardiovascular Devices (DCD)
- Division of General Restorative and Neurological Devices (DGRND).
How will the pilot program be implemented by the participating divisions?
The participating divisions will accept, on a case-by-case basis, PMA applications and 510(k) premarket notifications in the format described in the “draft STED document” in lieu of the customary format described in FDA regulations and guidances. Prior to preparing or submitting applications, manufacturers should contact one of the individuals listed in Section X of this document to inform FDA of their plans to participate in the pilot program. Manufacturers not participating may continue to make submissions in the customary format and content as described in FDA regulations and guidances.
Which devices are candidates for the pilot program?
Generic device types that may be accepted for premarket review in the pilot program are listed in Table 1 below.
Table 1: Candidate Devices for the STED Pilot Program
DIVISION DEVICE TYPE DAGID Intravascular Catheters
Anesthesia Catheters and Needles
External Infusion Pumps
Endosseus Dental Implants
DRARD Hemodialyzers and Hemodialysis Catheters
Plasma Cell Separators for Therapeutic Use
Computed Tomography Scanners
Magnetic Resonance Imaging Devices
DCD ECG Monitors
Anesthesia Catheters and Needles
Implantable Cardioverter Defibrillators
DGRND Orthopedic Implants
Will FDA consider additional devices for the STED pilot program that are not listed in Table 1?
Yes, FDA will consider additional types of devices for the STED pilot program other than those listed in Table 1. Consideration will be given on a case-by-case basis. Following a request from a manufacturer to have FDA review a specific device in the STED harmonized format, the agency will decide whether to grant the manufacturer’s request based on a variety of factors, including: (1) the level of interest among GHTF members to add the device(s) to the candidates list; (2) whether the affected CDRH Division(s) have sufficient resources to accept the additional device(s); and, (3) whether other manufacturers of the same device type would agree to prepare their submissions in the STED harmonized format.
Persons interested in adding a device type to Table 1 should contact one of the individuals listed in Section X. Although SG1 has been coordinating the pilot program and desires uniformity in the list of candidates, each GHTF member country has flexibility regarding how to conduct the pilot program within its own jurisdiction. Therefore, a particular device type may not be an eligible candidate for the pilot program in all countries.
What types of medical device submissions are excluded from the United States portion of the pilot premarket program?
The STED pilot program as implemented by FDA in the U.S. will not include 510(k) premarket notifications for submissions designated as “special” 510(k)s. Additionally, product development protocols (PDPs), humanitarian device exemptions (HDEs), PMA supplements and submissions that have been reviewed by third parties are not included in the pilot program.
What are the advantages to participating in the pilot program?
FDA encourages manufacturers who intend to submit PMA applications or 510(k) premarket notifications for any of the devices identified in Table 1, to consider participating in the pilot program. The manufacturers who choose to participate will be making an important contribution to the development of a harmonized regulatory review process. This will enable device manufacturers to gain market entry for their devices in a more efficient and cost-effective manner, while not compromising product safety and effectiveness.
While FDA cannot assure short-term advantages, cooperative, international efforts on pilot programs like this, between cooperating government and industry officials, are needed to forge progress in meeting the goals of FDA and the GHTF.
VI. ADMINISTRATIVE CONSIDERATIONS
Manufacturers intending to submit a PMA application or a 510(k) premarket notification and who are interested in participating in the STED pilot program should:
- Ensure that the medical device is subject to premarket review by FDA, i.e., it is not a Class I or a Class II exempt device.
- Verify that the device is listed in Table 1 as a candidate for this pilot program. If the device is subject to premarket review by DAGID, DRARD, DCD, or DGRND, but not listed in Table 1, FDA will consider including it in the pilot program on a case-by-case basis.
- Verify that the submission is not one of those excluded from this pilot. Only PMA applications, traditional 510(k)s, and abbreviated 510(k)s will be considered under this pilot premarket program. For definitions and more information on traditional and abbreviated 510(k) submissions, refer to the FDA guidance document entitled: “ The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” March 20, 1998.
- Early in the process, you should inform one of the individuals identified in Section X of your desire to participate in the pilot. FDA will promptly notify you as to whether you have been selected. It is possible that several manufacturers will respond to the call for harmonized submissions for one type of device. FDA is seeking to have a sample of submissions over a range of devices for the pilot program. The agency believes this is necessary for appropriate analysis of each type of submission.
- Once your device is determined to be acceptable for submission, you should follow the “draft STED document” when preparing your PMA application or 510(k) premarket notification. You should also include additional information as described in Sections VIII or IX below, either in your cover letter, as indicated, or as additional sections using the STED harmonized format.
- On the cover page, you should clearly identify the submission as being under the pilot program. Bold large print should indicate “Global Harmonization Pilot PMA Application” or “Global Harmonization Pilot 510(k) Submission,” as appropriate.
- Submit all relevant documents to: Document Mail Center HFZ-401, 9200 Corporate Blvd., Rockville, MD 20850. If you have any questions regarding the format or content of your submissions in connection with this pilot program, contact one of the individuals listed in Section X.
VII. THE BASIC PREMARKET SUBMISSION USING THE STED HARMONIZED FORMAT
Sections 6.1 and 6.3 of “the draft STED document” describe the basic format and content for a harmonized premarket submission. The cover letter should come first, followed by a table of contents. The following elements should then be provided:
- Executive Summary
- Essential Principles and Evidence of Conformity
- Device Description
- Summary Documents (engineering, preclinical, clinical)
- Risk Analysis
- Manufacturing Information
Each element of a harmonized premarket submission is described more fully in the “draft STED document.” With regard to the third element (Essential Principles and Evidence of Conformity), the “draft STED document” suggests that evidence of conformity to each relevant principle be provided in tabular form with supporting documentation. The relevant principles are outlined in GHTF's Essential Principles document.
FDA will consider any reasonable presentation of this information to be acceptable. For example, a declaration or statement of conformity to an applicable FDA-recognized standard is one way to demonstrate evidence of conformity to an Essential Principle. Please refer to additional FDA general or device-specific guidance for further information on engineering, preclinical, and/or clinical data that should be included in the submission.
With regard to labeling information, work is progressing at the international level to develop a harmonized format for labeling. Submitters should follow the guidance provided in the “draft STED document.” However, submitters are advised that the labeling provisions described in “draft STED document” may not be sufficient to meet U.S. labeling requirements. Where this is the case, submitters should provide additional data or information as necessary to satisfy those requirements.
VIII. HOW DO I SUBMIT A 510(k) USING THE “DRAFT STED DOCUMENT”?
A manufacturer planning to submit a 510(k) premarket notification in the STED harmonized format should follow the relevant provisions of the “draft STED document.” The submission should include the elements outlined in Section VII of this document, as applicable. Certain information required by FDA regulations must appear in your 510(k) submission even when using the “draft STED document” format (21 CFR 807.87). We suggest that you include the following at the beginning of your submission:
- Trade name and classification name of the device (807.87(a))
- Establishment registration number, if one is available (807.87(b))
- Device class or a statement that the device is not yet classified (807.87(c))
- 510(k) Summary or Statement (807.87(h))
- Financial Certification or Disclosure Statement for a 510(k) including a Clinical Study (807.87(i))
- Class III Certification and Summary (for all Class III devices under 510(k) authority) (807.87(j))
- Truthful and Accurate Statement (807.87(k))
- Indications for Use (807.87).
As part of the premarket notification process, FDA compares the specifications of a device that is planned for marketing to those for a similar device that is already legally on the market (predicate device). Only a device that is determined to be “substantially equivalent” to a predicate device, in terms of safety and efficacy, will be cleared for marketing.
The “draft STED document” addresses the subject of product comparisons under Section 7.2.1. Your submission of comparison data consistent with Section 7.2.1 will be considered adequate for review for purposes of determining substantial equivalency. This does not mean, however, that a finding of substantial equivalency will be made in all cases.
510(k) premarket notifications to FDA do not ordinarily include manufacturing information or risk analyses unless that information has been recommended in a product-specific guidance document. Premarket submissions to other countries may need to include these additional sections. FDA will review such information when it is provided in the 510(k) in response to an FDA product-specific guidance.
IX. HOW DO I SUBMIT A PMA USING THE “DRAFT STED DOCUMENT”?
A manufacturer submitting a PMA application in the STED harmonized format should follow the relevant provisions of the “draft STED document.” The submission should include the elements outlined in Section VII of this document, as applicable. However, the following information required by FDA regulations (21 CFR 814.20) must appear in the application even when using the “draft STED document”:
- Applicant’s name and address (814.20(b)(1))
- Summary (as described in section 814.20(b)(3))
- Justification for a single investigator (814.20(b)(7))
- Samples, if applicable (814.20(b)(9))
- Environmental assessment or exclusion (814.20(b)(11))
- Financial certification or disclosure statement 814.20(b)(12))
If you are interested in participating in the pilot program, or if you have any questions regarding the above, please contact one of the following individuals:
Harry R. Sauberman, P.EKenneth J. Cavanaugh Jr, Ph.D.