The US Food and Drug Administration (FDA) is over-reaching on its planned list of medical device guidance documents, claims a comment notice filed by industry group AdvaMed, which says FDA needs to focus on just seven final guidance documents and the completion of some already promised by the agency.
Background
Each year, the various centers of FDA publish lists detailing the guidance documents they plan to develop during the coming calendar year, which are often divided into two lists: documents which take priority (the "A" list) and documents which are of lesser importance (the "B" list).
In 2013 list developed by FDA's Center for Devices and Radiological health (CDRH) included 17 guidance documents, of which 13 are final guidance documents and four are draft guidance documents:
Final Guidance Topics: 'A' List | Draft Guidance Topics: 'A' List |
Refuse to Accept (RTA) Policy for 510(k) Submissions | Distinguishing and Reporting Medical Device Recalls from Product Enhancements |
Acceptance and Filing Review for Premarket Approval Applications | eCopy |
Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies | Types of Communication During the Review of Medical Device Submissions |
In Vitro Companion Diagnostic Devices | FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations |
Design Considerations for Pivotal Clinical Investigations for Medical Devices | Appropriate Use of Voluntary Consensus Standards in Premarket Submissions |
De Novo Classification Process (Evaluation of Automatic Class III Designation) | |
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications |
CDRH Appeals Processes |
Medical Device Classification Product Codes |
The Pre-Submission Program and Meetings with FDA Staff |
Mobile Medical Applications |
eCopy |
Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents |
Advamed Responds
But that list may be a bit too ambitious for industry taste, according to AdvaMed's comments. In offering up its comments on a "prioritization of the proposed FDA CDRH FY2013 guidance documents," the organization said it would like to see a focus on those documents with the potential to broadly affect the medical device industry, either in terms of initial effect or in affecting routine matters within the industry.
To that end, AdvaMed recommended that FDA concentrate its efforts on six final guidance documents and one draft guidance document that FDA had only considered important enough to be placed on the "B" list.
Those documents are:
'High Priority' Guidance Documents Not Included in FDA's FY2013 Guidance Lists |
Investigational Device Exemptions (IDE) for Early Feasibility Medical Device |
Clinical Studies, Including Certain First in Human (FIH) Studies |
Design Considerations for Pivotal Clinical Investigations for Medical Devices |
De Novo Classification Process (Evaluation of Automatic Class III Designation) |
The Pre-Submission Program and Meetings with FDA Staff |
In Vitro Companion Diagnostic Devices |
CDRH Appeals Process |
Benefit -Risk Determinations in Premarket Notifications (510(k)s) (Formerly on "B" List) |
Those documents are "of highest priority to our members," the organization noted. All other documents may be relegated to the "B" list of documents, it added.
Unfinished Guidance Documents
AdvaMed also said it wished to call attention to a number of unreleased guidance documents promised under previous iterations of the Medical Device User Fee Act (MDUFA), which is now on its third iteration since the passage of the FDA Safety and Innovation Act (FDASIA).
"There are a number of guidance documents/guidance document topics that are required according to the MDUFA III Commitment letter and/or FDASIA, have been draft for several years, or are of high priority to industry because of a lack of transparency/predictability that were not included in the FY 13 priority lists," AdvaMed wrote. The list of those documents is considerably longer than the list of documents proposed by FDA in FY2013.
Those recommended guidance documents fell into two groups: general guidance documents, and device-specific guidance documents.
General Guidance Documents | Device-Specific Guidance Documents |
Finalize "Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 15 10(k)1" | Commercially Distributed Diagnostic Products Labeled for Research Use Only or Investigational Use Only |
Guidance on CLIA Waiver Procedures (review and management expectations) | Co-Development Guidance (note: referenced in CDRH 2013 Strategic Priorities with goal by September 30, 2013) |
Update/revision of Least Burdensome guidance (see FDASIA, Sec. 602) | Framework for Regulatory Oversight of Laboratory Developed Tests |
Modify/update pre-1997 guidance on classification changes (see FDASIA, Sec. 608) | Guidance on leads (cardiac rhythm management) |
Modify/update Humanitarian Device Exemption guidance documents in accordance with FDASIA Sec. 613 | Guidance on troponin assay submissions (new review expectations) |
Re-issue "CDRH Manual for the Good Guidance Practices (GCP) Regulations Final Guidance for FDA Staff- " which was withdrawn in March 2012 (see FDASIA, Sec. 619) | |
Update guidance document on recruiting outside experts for Advisory Panels (See FDASIA, Sec. 1142) |
User Fees and Refunds for 510(k)s and PMAs (MDUFA III) |
Guidance on internet promotion, including social media |
Approval of pediatric devices (use of extrapolated data) |
Industry: Give us the Social Media Guidance
The list notably includes the so-called "social media guidance" on the use of social media websites such as Facebook, Twitter, LinkedIn, Pinterest and other modes of communication. Both pharmaceutical and medical device companies have been clamoring for more direction from the agency on the topic for nearly half a decade. Despite FDA's repeated promises, it has been slow to issue guidance.
One of the requirements contained within FDASIA calls for FDA to issue guidance on the topic by the end of 2013, and CDRH has said that it, too, plans to use social media to communicate more heavily with industry by the end of the year. Whether that use includes a three-way conversation involving FDA, industry and patients remains to be seen, but AdvaMed's comments indicate that it and its members would like that to be the case.