Regulatory Reform: Companies and Industry Groups Offer up a Wish List of CDER, CDRH Changes

Johnson & Johnson (J & J) and Abbott, as well as the PhRMA, BIO and AdvaMed industry group presented their priorities for the US Food and Drug Administration's (FDA) call to amend, repeal or replace regulations , according to comments Thursday on the register.

J & J have compiled a list of seven priorities that have been tabled for both CDER and CDRH, including reforms to simplify the way in which information from manufacturers who are not on a product label are disclosed; approval allow for changes to a label without FDA clearance, reducing conflicts of interest for FDA advisory committees (which PhRMA had also requested) and increasing the use of electronic labeling rather than paper.

J & J is also reviewing the FDA's decision to pause a voluntary quality data reporting program via an FDA portal after the industry has called on the agency to take the break.

"We are in agreement with the FDA that manufacturers of quality data to collect and analyze, but collects each company and analyze the data in its own way and adhering to a one-size-fits-all approach requires changes in heavy process. Cosmetic Act authorizes the FDA to require companies to collect data and submit the prescribed formats. We are compliant with the current pause in the additional input program from stakeholders and suggest that manufacturers should not enter to present data quality and statistics these data must be available for review during inspections, "says the comment.

PhRMA also called for changes in the FDA's guidelines on human factors research in the comments of the CDRH, while BIO called for regulatory changes for genetically modified animals.

Mutual approvals and inspections

J & J also suggests that mutual FDA approval of medical devices with the EU allows a medical device "class III ... save lives of vanguard additional data would be postmarketing place to access the patient's treatment options While the commitment is maintained The FDA requirements for Subparts B and C of 21 CFR 814 must be revised to reflect this approach. "

Abbott is appealing to the FDA to withdraw a proposed rule on the electronic submission of labels for certain home appliances that, in its opinion, is "superfluous because the labeling of devices is necessary to accompany medical devices used in distribution commercial. widely available to users and many home appliance manufacturers provide product labeling information on their websites. "

The AdvaMed group of Device Industry made 19 recommendations, covering everything from revisions to the use of symbols in the labeling rule, asking the FDA to consider a paper assessment rather than a prior on-site approval. .

"The increased use of evaluation by the production section of an LDC would save time. Approval inspections are intensive in terms of time and resources, "said the group, suggesting that a change could save $ 10 million.