Medtech Tips: 'Don't Be A Data Dump' When Submitting New Products For US FDA Review, Pre-Market Expert Says
Heather Rosecrans, former head of the FDA device center's 510(k) review staff, says manufacturers should be careful not to bombard the agency with a mountain of unnecessary information in new product submissions. She also offers advice on what firms should do if they run into problems with a reviewer.
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Nine device makers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.
US FDA commissioner Stephen Hahn and ORA associate commissioner for regulatory affairs Judith McMeekin said in a joint 24 February statement that the agency continues to aggressively monitor the market for firms selling products with fraudulent COVID-19 prevention and treatment claims. The officials also explained that the FDA has the authority under FDASIA to ask for records from drug manufacturers in lieu of conducting facility inspections. It can't do the same for device companies, however, because no similar provision exists. The FDA had announced on 14 February that it paused all inspections of Chinese manufacturing facilities in the near-term.
Philips Expert Urges Device Makers: Update Quality Systems To Conform To Revised Risk Standard ISO 14971
It’s time for manufacturers to begin adopting the new 2019 version of ISO 14971, the international standard for risk management widely used by industry. But firms need to do more work than just changing the date on risk-related procedures and documents to “2019,” says Jos Van Vroonhoven, a senior manager at Philips Healthcare who was intimately involved with the standard’s redo. From conducting gap assessments to creating cross-functional teams, both Van Vroonhoven and longtime industry expert Don Powers tell Medtech Insight how firms can keep their quality systems up-to-date to conform to ISO 14971:2019.