Devices

AdvaMed on Digital Breast Tomosynthesis Reclassification

AdvaMed says it is not taking a position on an FDA proposal to reclassify digital breast tomosynthesis systems from Class 3 into Class 2, but does have implementation concerns if the reclassification is approved. In its comment letter, the trade group says, “If FDA finalizes the proposed order, a clear, predictable, and appropriately phased transition will be essential to avoid unnecessary duplication, preserve regulatory continuity, and support consistent application of the new special controls.”

AdvaMed recommends that FDA:

establish clear transition provisions for approved DBT systems and pending PMAs and PMA supplements, including recognition of previously approved PMA devices as predicates under the new Class 2 framework;
make DBT-specific implementation guidance that explains the evidence, testing, comparator, and reader-qualification expectations associated with the special controls;
publish draft implementation guidance sufficiently in advance of the final order and provide an adequate implementation period;
apply evidence expectations proportionately to the nature and impact of a device modification and permit manufacturers to leverage prior evidence and targeted testing when scientifically justified;
clarify that appropriate predicate devices for DBT 510(k) submissions are other legally marketed DBT systems; and
clarify the regulatory treatment of accessories and auxiliary features under the reclassified DBT framework.

NDA Filed for Zipalertinib in Lung Cancer

Cullinan Therapeutics says its partner, Taiho Oncology, has filed an NDA for zipalertinib in combination with platinum-based chemotherapy for treating patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. he submission was made

FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

FDA Oncology Center of Excellence director Angelo De Claro says the center has retained its core regulatory experts despite staffing reductions across the agency and is pursuing new collaborations with the Department of Veterans Affairs and National Cancer Institute to modernize oncology clinical trials. Speaking during an 11/10 fireside

FDA Posts 20 Form 483 Inspection Records

FDA has posted 20 Form 483 inspection records (see below), including reports involving sterile drug manufacturer Huons in South Korea, Bora Pharmaceutical Laboratories in Taiwan, Genzyme Ireland, Similasan in Switzerland, and medical device manufacturers in the U.S. and overseas. Their availability is part of the agency’s expanded transparency

Modest Device Material Change May Need New 510(k): Post

Even seemingly modest medical device material changes such as new colorants, a different preservative, or a reformulated component sourced from a new supplier, may require submission of a new 510(k) to FDA. That’s the advice from principal medical device regulation expert Adrienne Lentz (Hyman, Phelps & McNamara) in

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NDA Filed for Zipalertinib in Lung Cancer

FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

FDA Posts 20 Form 483 Inspection Records

Modest Device Material Change May Need New 510(k): Post